U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry ABSOLUTE
Molecular Formula C19H20N4O.C7H8O3S.H2O
Molecular Weight 510.605
Optical Activity UNSPECIFIED
Defined Stereocenters 1 / 1
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of Niraparib tosylate monohydrate

SMILES

O.CC1=CC=C(C=C1)S(O)(=O)=O.NC(=O)C2=CC=CC3=CN(N=C23)C4=CC=C(C=C4)[C@@H]5CCCNC5

InChI

InChIKey=ACNPUCQQZDAPJH-FMOMHUKBSA-N
InChI=1S/C19H20N4O.C7H8O3S.H2O/c20-19(24)17-5-1-3-15-12-23(22-18(15)17)16-8-6-13(7-9-16)14-4-2-10-21-11-14;1-6-2-4-7(5-3-6)11(8,9)10;/h1,3,5-9,12,14,21H,2,4,10-11H2,(H2,20,24);2-5H,1H3,(H,8,9,10);1H2/t14-;;/m1../s1

HIDE SMILES / InChI
Molecular Formula C7H8O3S
Molecular Weight 172.202
Charge 0
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE
Molecular Formula H2O
Molecular Weight 18.0153
Charge 0
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE
Molecular Formula C19H20N4O
Molecular Weight 320.3883
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 1 / 1
E/Z Centers 0
Optical Activity UNSPECIFIED

Description
Curator's Comment: Description was created based on several sources, including https://www.ncbi.nlm.nih.gov/pubmed/19873981 | https://www.ncbi.nlm.nih.gov/pubmed/25761096

Niraparib (MK-4827) displays excellent PARP 1 and 2 inhibition. Inhibition of PARP in the context of defects in other DNA repair mechanisms provide a tumor specific way to kill cancer cells. Niraparib is in development with TESARO, under licence from Merck & Co, for the treatment of cancers (ovarian, fallopian tube and peritoneal cancer, breast cancer, prostate cancer and Ewing's sarcoma). Niraparib was characterized in a number of preclinical models before moving to phase I clinical trials, where it showed excellent human pharmacokinetics suitable for once a day oral dosing, achieved its pharmacodynamic target for PARP inhibition, and had promising activity in cancer patients. It is currently being tested in phase 3 clinical trials as maintenance therapy in ovarian cancer and as a treatment for breast cancer.

CNS Activity

CNS Active
3913
Curator's Comment: Niraparib is able to penetrate the brain in rodents. No human data available.

Originator

Merck
216
Curator's Comment: # Merck & Co. Inc.

Approval Year

2017
422
Targets

Targets

Primary TargetPharmacologyConditionPotency
Inhibitor
8297
 3.8 nM [IC50]
Inhibitor
8297
 2.1 nM [IC50]
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
Approved
8429
ZEJULA

Approved Use

ZEJULA is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Launch Date

1.49048643E12
Primary
Phase III
656
Unknown

Approved Use

Unknown
Primary
Phase III
656
Unknown

Approved Use

Unknown
Primary
Phase III
656
Unknown

Approved Use

Unknown
Primary
Phase III
656
Unknown

Approved Use

Unknown
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
803.7 ng/mL
EXPERIMENT
https://www.ncbi.nlm.nih.gov/pubmed/29322231
300 mg single, oral
dose: 300 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
NIRAPARIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
804 ng/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208447s014lbl.pdf
300 mg single, oral
dose: 300 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
NIRAPARIB plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
29016.1 ng × h/mL
EXPERIMENT
https://www.ncbi.nlm.nih.gov/pubmed/29322231
300 mg single, oral
dose: 300 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
NIRAPARIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
50.5 h
EXPERIMENT
https://www.ncbi.nlm.nih.gov/pubmed/29322231
300 mg single, oral
dose: 300 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
NIRAPARIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
17%
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208447s014lbl.pdf
300 mg single, oral
dose: 300 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
NIRAPARIB plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
Doses

Doses

DosePopulationAdverse events​
400 mg 1 times / day steady, oral
Highest studied dose
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
unhealthy, 59 years (range: 39–75 years)
n = 6
Health Status: unhealthy
Condition: advanced solid tumours
Age Group: 59 years (range: 39–75 years)
Sex: M+F
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
DLT: Thrombocytopenia...
Other AEs: Neutropenia, Neutropenia...
Dose limiting toxicities:
Thrombocytopenia (grade 4, 2 patients)
Other AEs:
Neutropenia (grade 1-2, 3 patients)
Neutropenia (grade 3, 1 patient)
Lymphopenia (grade 3, 1 patient)
Nausea (grade 1-2, 3 patients)
Vomiting (grade 1-2, 3 patients)
Constipation (grade 1-2, 2 patients)
Anorexia (grade 1-2, 2 patients)
Fatigue (grade 1-2, 4 patients)
Insomnia (grade 1-2, 2 patients)
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
unhealthy, 59 years (range: 39–75 years)
n = 6
Health Status: unhealthy
Condition: advanced solid tumours
Age Group: 59 years (range: 39–75 years)
Sex: M+F
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
DLT: Fatigue...
Dose limiting toxicities:
Fatigue (grade 3, 1 patient)
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
60 mg 1 times / day steady, oral
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
unhealthy, 59 years (range: 39–75 years)
n = 7
Health Status: unhealthy
Condition: advanced solid tumours
Age Group: 59 years (range: 39–75 years)
Sex: M+F
Population Size: 7
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
DLT: Pneumonitis...
Dose limiting toxicities:
Pneumonitis (grade 3, 1 patient)
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Disc. AE: Thrombocytopenia, Anemia...
Other AEs: Thrombocytopenia, Thrombocytopenia...
AEs leading to
discontinuation/dose reduction:
Thrombocytopenia (3%)
Anemia (1%)
Neutropenia (2%)
Hypertension (<1%)
Myelodysplastic syndrome (grade 5, 1 patient)
Other AEs:
Thrombocytopenia (grade 1-2, 32%)
Thrombocytopenia (grade 3-4, 29%)
Anemia (grade 1-2, 25%)
Anemia (grade 3-4, 25%)
Neutropenia (grade 1-2, 10%)
Neutropenia (grade 3-4, 20%)
Leukopenia (grade 1-2, 12%)
Leukopenia (grade 3-4, 5%)
Palpitations (grade 1-2, 10%)
Nausea (grade 1-2, 71%)
Nausea (grade 3-4, 3%)
Abdominal distension (grade 1-2, 31%)
Abdominal distension (grade 3-4, 2%)
Vomiting (grade 1-2, 32%)
Vomiting (grade 3-4, 2%)
Constipation (grade 1-2, 39.2%)
Constipation (grade 3-4, 0.8%)
Mucositis (grade 1-2, 19.5%)
Mucositis (grade 3-4, 0.5%)
Stomatitis (grade 1-2, 19.5%)
Stomatitis (grade 3-4, 0.5%)
Diarrhea (grade 1-2, 19.7%)
Diarrhea (grade 3-4, 0.3%)
Dyspepsia (grade 1-2, 18%)
Dry mouth (grade 1-2, 9.7%)
Dry mouth (grade 3-4, 0.3%)
Fatigue (grade 1-2, 49%)
Fatigue (grade 1-2, 49%)
Asthenia (grade 3-4, 8%)
Asthenia (grade 3-4, 8%)
Decreased appetite (grade 1-2, 24.7%)
Decreased appetite (grade 3-4, 0.3%)
Urinary tract infection (grade 1-2, 12.2%)
Urinary tract infection (grade 3-4, 0.8%)
Aspartate aminotransferase increased (grade 1-2, 6%)
Aspartate aminotransferase increased (grade 3-4, 4%)
Alanine aminotransferase increase (grade 1-2, 6%)
Alanine aminotransferase increase (grade 3-4, 4%)
Myalgia (grade 1-2, 18.2%)
Myalgia (grade 3-4, 0.8%)
Back pain (grade 1-2, 17.2%)
Back pain (grade 3-4, 0.8%)
Arthralgia (grade 1-2, 12.7%)
Arthralgia (grade 3-4, 0.3%)
Headache (grade 1-2, 25.7%)
Headache (grade 3-4, 0.3%)
Dizziness (grade 1-2, 18%)
Dysgeusia (grade 1-2, 10%)
Insomnia (grade 1-2, 26.7%)
Insomnia (grade 3-4, 0.3%)
Anxiety (grade 1-2, 10.7%)
Anxiety (grade 3-4, 0.3%)
Nasopharyngitis (grade 1-2, 23%)
Dyspnea (grade 1-2, 19%)
Dyspnea (grade 3-4, 1%)
Cough (grade 1-2, 16%)
Rash (grade 1-2, 20.5%)
Rash (grade 3-4, 0.5%)
Hypertension (grade 1-2, 11%)
Hypertension (grade 3-4, 9%)
Decreased hemoglobin (grade 1-2, 60%)
Decreased hemoglobin (grade 3-4, 25%)
Platelet count decreased (grade 1-2, 37%)
Platelet count decreased (grade 3-4, 35%)
WBC decreased (grade 1-2, 59%)
WBC decreased (grade 3-4, 7%)
Absolute neutrophil count decreased (grade 1-2, 32%)
Absolute neutrophil count decreased (grade 3-4, 21%)
Myelodysplastic syndrome (all grades, 1.4%)
Tachycardia (1-10)
Peripheral edema (1-10)
Hypokalemia (1-10)
Bronchitis (1-10)
Conjunctivitis (1-10)
Gamma-glutamyltransferase increased (1-10)
Blood creatinine increased (1-10)
Blood alkaline phosphatase increased (1-10)
Weight decreased (1-10)
Depression (1-10)
Epistaxis (1-10)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
AEs

AEs

AESignificanceDosePopulation
Anorexia grade 1-2, 2 patients
400 mg 1 times / day steady, oral
Highest studied dose
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
unhealthy, 59 years (range: 39–75 years)
n = 6
Health Status: unhealthy
Condition: advanced solid tumours
Age Group: 59 years (range: 39–75 years)
Sex: M+F
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
Constipation grade 1-2, 2 patients
400 mg 1 times / day steady, oral
Highest studied dose
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
unhealthy, 59 years (range: 39–75 years)
n = 6
Health Status: unhealthy
Condition: advanced solid tumours
Age Group: 59 years (range: 39–75 years)
Sex: M+F
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
Insomnia grade 1-2, 2 patients
400 mg 1 times / day steady, oral
Highest studied dose
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
unhealthy, 59 years (range: 39–75 years)
n = 6
Health Status: unhealthy
Condition: advanced solid tumours
Age Group: 59 years (range: 39–75 years)
Sex: M+F
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
Nausea grade 1-2, 3 patients
400 mg 1 times / day steady, oral
Highest studied dose
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
unhealthy, 59 years (range: 39–75 years)
n = 6
Health Status: unhealthy
Condition: advanced solid tumours
Age Group: 59 years (range: 39–75 years)
Sex: M+F
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
Neutropenia grade 1-2, 3 patients
400 mg 1 times / day steady, oral
Highest studied dose
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
unhealthy, 59 years (range: 39–75 years)
n = 6
Health Status: unhealthy
Condition: advanced solid tumours
Age Group: 59 years (range: 39–75 years)
Sex: M+F
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
Vomiting grade 1-2, 3 patients
400 mg 1 times / day steady, oral
Highest studied dose
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
unhealthy, 59 years (range: 39–75 years)
n = 6
Health Status: unhealthy
Condition: advanced solid tumours
Age Group: 59 years (range: 39–75 years)
Sex: M+F
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
Fatigue grade 1-2, 4 patients
400 mg 1 times / day steady, oral
Highest studied dose
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
unhealthy, 59 years (range: 39–75 years)
n = 6
Health Status: unhealthy
Condition: advanced solid tumours
Age Group: 59 years (range: 39–75 years)
Sex: M+F
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
Lymphopenia grade 3, 1 patient
400 mg 1 times / day steady, oral
Highest studied dose
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
unhealthy, 59 years (range: 39–75 years)
n = 6
Health Status: unhealthy
Condition: advanced solid tumours
Age Group: 59 years (range: 39–75 years)
Sex: M+F
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
Neutropenia grade 3, 1 patient
400 mg 1 times / day steady, oral
Highest studied dose
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
unhealthy, 59 years (range: 39–75 years)
n = 6
Health Status: unhealthy
Condition: advanced solid tumours
Age Group: 59 years (range: 39–75 years)
Sex: M+F
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
Thrombocytopenia grade 4, 2 patients
DLT, Disc. AE
400 mg 1 times / day steady, oral
Highest studied dose
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
unhealthy, 59 years (range: 39–75 years)
n = 6
Health Status: unhealthy
Condition: advanced solid tumours
Age Group: 59 years (range: 39–75 years)
Sex: M+F
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
Fatigue grade 3, 1 patient
DLT
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
unhealthy, 59 years (range: 39–75 years)
n = 6
Health Status: unhealthy
Condition: advanced solid tumours
Age Group: 59 years (range: 39–75 years)
Sex: M+F
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
Pneumonitis grade 3, 1 patient
DLT
60 mg 1 times / day steady, oral
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
unhealthy, 59 years (range: 39–75 years)
n = 7
Health Status: unhealthy
Condition: advanced solid tumours
Age Group: 59 years (range: 39–75 years)
Sex: M+F
Population Size: 7
Sources:
https://pubmed.ncbi.nlm.nih.gov/23810788/
Anemia 1%
Disc. AE
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Blood alkaline phosphatase increased 1-10
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Blood creatinine increased 1-10
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Bronchitis 1-10
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Conjunctivitis 1-10
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Depression 1-10
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Epistaxis 1-10
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Gamma-glutamyltransferase increased 1-10
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Hypokalemia 1-10
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Peripheral edema 1-10
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Tachycardia 1-10
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Weight decreased 1-10
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Neutropenia 2%
Disc. AE
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Thrombocytopenia 3%
Disc. AE
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Hypertension <1%
Disc. AE
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Myelodysplastic syndrome all grades, 1.4%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Dysgeusia grade 1-2, 10%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Neutropenia grade 1-2, 10%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Palpitations grade 1-2, 10%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Anxiety grade 1-2, 10.7%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Hypertension grade 1-2, 11%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Leukopenia grade 1-2, 12%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Urinary tract infection grade 1-2, 12.2%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Arthralgia grade 1-2, 12.7%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Cough grade 1-2, 16%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Back pain grade 1-2, 17.2%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Dizziness grade 1-2, 18%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Dyspepsia grade 1-2, 18%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Myalgia grade 1-2, 18.2%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Dyspnea grade 1-2, 19%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Mucositis grade 1-2, 19.5%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Stomatitis grade 1-2, 19.5%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Diarrhea grade 1-2, 19.7%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Rash grade 1-2, 20.5%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Nasopharyngitis grade 1-2, 23%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Decreased appetite grade 1-2, 24.7%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Anemia grade 1-2, 25%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Headache grade 1-2, 25.7%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Insomnia grade 1-2, 26.7%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Abdominal distension grade 1-2, 31%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Absolute neutrophil count decreased grade 1-2, 32%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Thrombocytopenia grade 1-2, 32%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Vomiting grade 1-2, 32%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Platelet count decreased grade 1-2, 37%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Constipation grade 1-2, 39.2%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Fatigue grade 1-2, 49%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Fatigue grade 1-2, 49%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
WBC decreased grade 1-2, 59%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Alanine aminotransferase increase grade 1-2, 6%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Aspartate aminotransferase increased grade 1-2, 6%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Decreased hemoglobin grade 1-2, 60%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Nausea grade 1-2, 71%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Dry mouth grade 1-2, 9.7%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Anxiety grade 3-4, 0.3%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Arthralgia grade 3-4, 0.3%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Decreased appetite grade 3-4, 0.3%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Diarrhea grade 3-4, 0.3%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Dry mouth grade 3-4, 0.3%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Headache grade 3-4, 0.3%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Insomnia grade 3-4, 0.3%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Mucositis grade 3-4, 0.5%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Rash grade 3-4, 0.5%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Stomatitis grade 3-4, 0.5%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Back pain grade 3-4, 0.8%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Constipation grade 3-4, 0.8%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Myalgia grade 3-4, 0.8%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Urinary tract infection grade 3-4, 0.8%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Dyspnea grade 3-4, 1%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Abdominal distension grade 3-4, 2%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Vomiting grade 3-4, 2%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Neutropenia grade 3-4, 20%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Absolute neutrophil count decreased grade 3-4, 21%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Anemia grade 3-4, 25%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Decreased hemoglobin grade 3-4, 25%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Thrombocytopenia grade 3-4, 29%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Nausea grade 3-4, 3%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Platelet count decreased grade 3-4, 35%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Alanine aminotransferase increase grade 3-4, 4%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Aspartate aminotransferase increased grade 3-4, 4%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Leukopenia grade 3-4, 5%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
WBC decreased grade 3-4, 7%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Asthenia grade 3-4, 8%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Asthenia grade 3-4, 8%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Hypertension grade 3-4, 9%
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Myelodysplastic syndrome grade 5, 1 patient
Disc. AE
300 mg 1 times / day steady, oral
Recommended|MTD
Dose: 300 mg, 1 times / day
Route: oral
Route: steady
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
unhealthy
n = 367
Health Status: unhealthy
Condition: platinum-sensitive recurrent ovarian cancer | fallopian tube cancer|primary peritoneal cancer
Population Size: 367
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG
inducer
781
inhibitor
1767
substrate
1217

inhibitor
1852
inhibitor
1612

OverviewOther

Other InhibitorOther SubstrateOther Inducer
OCT1
512

BCRP
699

OATP1B1
788

OATP1B3
706

OAT1
599

OAT3
642

OCT2
647

BSEP
402

CYP1A
72

CYP2B6
810

CYP2C8
911

CYP2C19
1478

CYP3A4/5
278

P-gp
1461

MATE1
306

MATE2
263
BCRP
561

P-gp
1537

CYP1A2
1054

CYP3A4/5
85

UGT
192

OATP1B1
406

OATP1B3
350

OCT1
327

OAT1
326

OAT3
339

OCT2
355

BSEP
52

MATE1
135

MATE2
96
CYP1A2
701
Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
BCRP
773
 no
M1
8
BSEP
403
 no
BSEP
403
 no
M1
8
CYP1A
121
 no
CYP1A
121
 no
M1
8
CYP1A2
1692
 no
M1
8
CYP2B6
1001
 no
CYP2B6
1001
 no
M1
8
CYP2C19
1553
 no
CYP2C19
1553
 no
M1
8
CYP2C8
965
 no
CYP2C8
965
 no
M1
8
CYP2C9
1819
 no
CYP2C9
1819
 no
M1
8
CYP2D6
1891
 no
CYP2D6
1891
 no
M1
8
CYP3A4
1925
 no
CYP3A4
1925
 no
M1
8
CYP3A4/5
335
 no
CYP3A4/5
335
 no
M1
8
MATE1
308
 no
M1
8
MATE2
263
 no
M1
8
OAT1
603
 no
OAT1
603
 no
M1
8
OAT3
644
 no
OAT3
644
 no
M1
8
OATP1B1
803
 no
OATP1B1
803
 no
M1
8
OATP1B3
715
 no
OATP1B3
715
 no
M1
8
OCT2
648
 no
OCT2
648
 no
M1
8
P-gp
1650
 no
M1
8
P-gp
1650
 weak [Inhibition 161 uM]
CYP1A2
1692
 weak
OCT1
543
 weak
BCRP
773
 yes [IC50 1.21 uM]
MATE1
308
 yes [Inhibition 0.18 uM]
MATE2
263
 yes [Inhibition <0.14 uM]
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
BCRP
561
 no
M1
13
BSEP
52
 no
BSEP
52
 no
M1
13
MATE1
135
 no
MATE2
96
 no
OAT1
326
 no
OAT1
326
 no
M1
13
OAT3
339
 no
OAT3
339
 no
M1
13
OATP1B1
406
 no
OATP1B1
406
 no
M1
13
OATP1B3
350
 no
OATP1B3
350
 no
M1
13
OCT1
327
 no
OCT1
327
 no
M1
13
OCT2
355
 no
OCT2
355
 no
M1
13
P-gp
1537
 no
M1
13
BCRP
561
 yes
CYP1A2
1054
 yes
CYP2D6
1217
 yes
CYP3A4/5
85
 yes
MATE1
135
 yes
M1
13
MATE2
96
 yes
M1
13
P-gp
1537
 yes
UGT
192
 yes
Tox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
hERG
1647
Sourcing

Sourcing

Vendor/AggregatorIDURL
AA Blocks
AA0038X2
https://www.aablocks.com/goods/Goods/detail?id=AA0038X2
AK Scientific, Inc. (AKSCI)
0919AA
http://www.aksci.com/item_detail.php?cat=0919AA
Aaron Chemicals
AR0039OU
http://www.aaronchem.com/1038915-60-4
AbMole Bioscience
M2215
http://www.abmole.com/products/mk-4827.html
Achemo Scientific Limited
AC-86985
http://www.achemo.com/search/?Keyword= 1038915-60-4
Achemtek
0102-029640
http://www.achemtek.com/1038915-60-4
Adooq BioScience
MK-4827
http://www.adooq.com/mk-4827.html
Adooq BioScience
A11026
https://www.adooq.com/mk-4827.html
Ambinter
Amb22388574
http://www.ambinter.com/reference/22388574
Angene
AGN-PC-0OSO5V
http://www.angenechemical.com/productshow/AGN-PC-0OSO5V.html
Anward
ANW-62065
http://www.anward.com/pro_result/48516
ApexBio Technology
A3617
http://www.apexbt.com/mk-9380.html
Aurum Pharmatech LLC
W-5696
http://www.Aurumpharmatech.com/Product/ProductDetails/W_5696
Axon MedChem
2928
https://www.axonmedchem.com/product/2928
BLD Pharm
BD234046
http://www.bldpharm.com/products/1038915-60-4.html
BioCrick
BCC1761
http://www.biocrick.com/MK-4827-BCC1761.html
CSNpharm
CSN13146
https://www.csnpharm.com/products/mk-4827.html
Chem Scene
CS-0780
http://www.chemscene.com/1038915-60-4.html
Chemspace
CSSB00015193672
https://chem-space.com/CSSB00015193672
DAOGE BIOPHARMA
DG21-13343
https://www.daogechem.com/product/1038915-60-4.html
Excenen
EX-A290
http://www.excenen.com/searchresultlist.php?id=1038915-60-4
Lab Network
LN01331029
https://labnetwork.com/frontend-app/p/#!/moleculedetails/LN01331029
Matrix Scientific
153552
https://www.matrixscientific.com/153552.html
MedChem Express
HY-10619
https://www.medchemexpress.com/MK-4827.html
Smolecule
S537248
http://www.smolecule.com/products/s537248
Smolecule
S746643
https://www.smolecule.com/products/s746643
Synblock Inc
SB16547
http://www.synblock.com/product/1038915-60-4.html
THE BioTek
bt-277148
https://www.thebiotek.com/product/inhibitors/bt-277148
Tenova Pharmaceuticals Inc
T31004
https://www.tenovapharma.com/Niraparib
Yuhao Chemical
YH65274
http://www.chemyuhao.com/1038915-60-4.html
abcr GmbH
AB435856
http://www.abcr.com/shop/en/AB435856
eNovation Chemicals
D388300
http://www.enovationchem.com/productDetails.asp?productID=D388300
iChemical
EBD2206766
http://www.ichemical.com/products/1038915-60-4.html?utm_source=PubChem&utm_medium=website&utm_campaign=product%20catalogs
PubMed

PubMed

TitleDatePubMed
Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers.
2009 Jul 9
The Role of PARP Inhibitors in the Treatment of Gynecologic Malignancies.
2013 Oct 1
Patents

Patents

20080167345
4
20100286203
4

Sample Use Guides

In Vivo Use Guide
Niraparib (PO, 110-210 mg) successfully inhibited poly(ADP-ribose) polymerase (PARP) during a phase I trial in patients with BRCA-deficient or sporadic cancers associated with homologous recombination repair defects. Niraparib (PO, 30-210 mg) was well tolerated during a phase I trial in patients with BRCA-deficient or sporadic cancers associated with homologous recombination repair defects. Maximum tolerated dose (MTD) of niraparib in patients with advanced solid tumours was 300 mg.
Route of Administration: Oral
In Vitro Use Guide
Niraparib (MK-4827) inhibited proliferation of cancer cells with mutant BRCA-1 and BRCA-2 with CC(50) in the 10-100 nM range.
Substance Class Chemical
Created
by admin
on Sat Dec 16 09:12:11 UTC 2023
Edited
by admin
on Sat Dec 16 09:12:11 UTC 2023
Record UNII
195Q483UZD
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
Niraparib tosylate monohydrate
Common Name English
ZEJULA
Brand Name English
AKEEGA COMPONENT NIRAPARIB TOSYLATE MONOHYDRATE
Brand Name English
2H-Indazole-7-carboxamide, 2-[4-(3S)-3-piperidinylphenyl]-, 4-methylbenzenesulfonate, hydrate (1:1:1)
Systematic Name English
MK-4827 TOSYLATE MONOHYDRATE
Code English
NIRAPARIB TOSILATE HYDRATE
Common Name English
NIRAPARIB TOSYLATE MONOHYDRATE COMPONENT OF AKEEGA
Brand Name English
NIRAPARIB TOSYLATE MONOHYDRATE [MI]
Common Name English
NIRAPARIB TOSILATE HYDRATE [JAN]
Common Name English
Niraparib tosylate monohydrate [WHO-DD]
Common Name English
Classification Tree Code System Code
NCI_THESAURUS C62554
Created by admin on Sat Dec 16 09:12:11 UTC 2023 , Edited by admin on Sat Dec 16 09:12:11 UTC 2023
Code System Code Type Description
EU-Orphan Drug
EU/3/10/760(POSITIVE)
Created by admin on Sat Dec 16 09:12:11 UTC 2023 , Edited by admin on Sat Dec 16 09:12:11 UTC 2023
PRIMARY On 4 August 2010, orphan designation (EU/3/10/760) was granted by the European Commission to Merck Sharp & Dohme Limited, United Kingdom, for (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt (also known as MK-4827) for the treatment of ovarian cancer. The sponsorship was transferred to Tesaro U.K. Limited, United Kingdom, in December 2012.
FDA UNII
195Q483UZD
Created by admin on Sat Dec 16 09:12:11 UTC 2023 , Edited by admin on Sat Dec 16 09:12:11 UTC 2023
PRIMARY
CAS
1613220-15-7
Created by admin on Sat Dec 16 09:12:11 UTC 2023 , Edited by admin on Sat Dec 16 09:12:11 UTC 2023
PRIMARY
EVMPD
SUB183938
Created by admin on Sat Dec 16 09:12:11 UTC 2023 , Edited by admin on Sat Dec 16 09:12:11 UTC 2023
PRIMARY
SMS_ID
100000170106
Created by admin on Sat Dec 16 09:12:11 UTC 2023 , Edited by admin on Sat Dec 16 09:12:11 UTC 2023
PRIMARY
PUBCHEM
74763937
Created by admin on Sat Dec 16 09:12:11 UTC 2023 , Edited by admin on Sat Dec 16 09:12:11 UTC 2023
PRIMARY
MERCK INDEX
m11995
Created by admin on Sat Dec 16 09:12:11 UTC 2023 , Edited by admin on Sat Dec 16 09:12:11 UTC 2023
PRIMARY
DRUG BANK
DBSALT002590
Created by admin on Sat Dec 16 09:12:11 UTC 2023 , Edited by admin on Sat Dec 16 09:12:11 UTC 2023
PRIMARY
NCI_THESAURUS
C133238
Created by admin on Sat Dec 16 09:12:11 UTC 2023 , Edited by admin on Sat Dec 16 09:12:11 UTC 2023
PRIMARY
CHEBI
176844
Created by admin on Sat Dec 16 09:12:11 UTC 2023 , Edited by admin on Sat Dec 16 09:12:11 UTC 2023
PRIMARY
EU-Orphan Drug
EU/3/10/787(POSITIVE)
Created by admin on Sat Dec 16 09:12:11 UTC 2023 , Edited by admin on Sat Dec 16 09:12:11 UTC 2023
PRIMARY On 1 October 2010, orphan designation (EU/3/10/787) was granted by the European Commission to Merck Sharp & Dohme Limited, United Kingdom, for (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt for the treatment of mantle-cell lymphoma. The sponsorship was transferred to Tesaro U.K. Limited, United Kingdom, in December 2012.
Related Record Type Details
Structure of NIRAPARIB
PARENT -> SALT/SOLVATE
Structure of NIRAPARIB TOSYLATE ANHYDROUS
ANHYDROUS->SOLVATE
Related Record Type Details
Structure of NIRAPARIB
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