Details
Stereochemistry | ACHIRAL |
Molecular Formula | C22H23N3O4 |
Molecular Weight | 393.4357 |
Optical Activity | NONE |
Defined Stereocenters | 0 / 0 |
E/Z Centers | 0 |
Charge | 0 |
SHOW SMILES / InChI
SMILES
COCCOC1=CC2=C(C=C1OCCOC)C(NC3=CC(=CC=C3)C#C)=NC=N2
InChI
InChIKey=AAKJLRGGTJKAMG-UHFFFAOYSA-N
InChI=1S/C22H23N3O4/c1-4-16-6-5-7-17(12-16)25-22-18-13-20(28-10-8-26-2)21(29-11-9-27-3)14-19(18)23-15-24-22/h1,5-7,12-15H,8-11H2,2-3H3,(H,23,24,25)
Molecular Formula | C22H23N3O4 |
Molecular Weight | 393.4357 |
Charge | 0 |
Count |
|
Stereochemistry | ACHIRAL |
Additional Stereochemistry | No |
Defined Stereocenters | 0 / 0 |
E/Z Centers | 0 |
Optical Activity | NONE |
DescriptionSources: http://www.drugbank.ca/drugs/DB00530Curator's Comment: Description was created based on several sources, including
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021743s14s16lbl.pdf
Sources: http://www.drugbank.ca/drugs/DB00530
Curator's Comment: Description was created based on several sources, including
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021743s14s16lbl.pdf
Erlotinib hydrochloride (trade name Tarceva, Genentech/OSIP, originally coded as OSI-774) is a drug used to treat non-small cell lung cancer, pancreatic cancer and several other types of cancer. Similar to gefitinib, erlotinib specifically targets the epidermal growth factor receptor (EGFR) tyrosine kinase. It binds in a reversible fashion to the adenosine triphosphate (ATP) binding site of the receptor. Erlotinib has recently been shown to be a potent inhibitor of JAK2V617F activity. JAK2V617F is a mutant of tyrosine kinase JAK2, is found in most patients with polycythemia vera (PV) and a substantial proportion of patients with idiopathic myelofibrosis or essential thrombocythemia. The study suggests that erlotinib may be used for treatment of JAK2V617F-positive PV and other myeloproliferative disorders. The mechanism of clinical antitumor action of erlotinib is not fully characterized. Erlotinib inhibits the intracellular phosphorylation of tyrosine kinase associated with the epidermal growth factor receptor (EGFR). Specificity of inhibition with regard to other tyrosine kinase receptors has not been fully characterized. EGFR is expressed on the cell surface of normal cells and cancer cells.
CNS Activity
Originator
Approval Year
Targets
Primary Target | Pharmacology | Condition | Potency |
---|---|---|---|
Target ID: CHEMBL203 Sources: https://www.ncbi.nlm.nih.gov/pubmed/25882519 |
1.2 nM [IC50] | ||
Target ID: CHEMBL3401 Sources: http://www.drugbank.ca/drugs/DB00530 |
|||
Target ID: CHEMBL5393 Sources: https://www.ncbi.nlm.nih.gov/pubmed/27418107 |
2.23 µM [IC50] | ||
Target ID: CHEMBL614139 Sources: https://www.ncbi.nlm.nih.gov/pubmed/27010345 |
0.02 µM [IC50] | ||
Target ID: CHEMBL5145 Sources: https://www.ncbi.nlm.nih.gov/pubmed/27010345 |
0.08 µM [IC50] | ||
Target ID: CHEMBL2363049 Sources: https://www.ncbi.nlm.nih.gov/pubmed/27010345 |
0.05 µM [IC50] |
Conditions
Condition | Modality | Targets | Highest Phase | Product |
---|---|---|---|---|
Primary | TARCEVA Approved UseTARCEVA is a kinase inhibitor indicated for:
Maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
Treatment of locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. Launch Date2004 |
|||
Primary | TARCEVA Approved UseTARCEVA is a kinase inhibitor indicated for:
Maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
Treatment of locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. Launch Date2004 |
Cmax
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
1.25 μg/mL EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/19956953 |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
ERLOTINIB plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN |
|
4.07 μg/mL EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/19956953 |
100 mg single, intravenous dose: 100 mg route of administration: Intravenous experiment type: SINGLE co-administered: |
ERLOTINIB plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
|
1969.5 ng/mL Clinical Trial https://clinicaltrials.gov/ct2/show/NCT01032070 |
85 mg/m^2 1 times / day steady, oral dose: 85 mg/m^2 route of administration: oral experiment type: steady co-administered: |
ERLOTINIB plasma | Homo sapiens population: unhealthy age: Children sex: food status: |
AUC
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
29.9 μg × h/mL EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/19956953 |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
ERLOTINIB plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN |
|
32 μg × h/mL EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/19956953 |
100 mg single, intravenous dose: 100 mg route of administration: Intravenous experiment type: SINGLE co-administered: |
ERLOTINIB plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
|
26716.7 ng*h/mL Clinical Trial https://clinicaltrials.gov/ct2/show/NCT01032070 |
85 mg/m^2 1 times / day steady, oral dose: 85 mg/m^2 route of administration: oral experiment type: steady co-administered: |
ERLOTINIB plasma | Homo sapiens population: unhealthy age: Children sex: food status: |
T1/2
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
14.4 h EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/19956953 |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
ERLOTINIB plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN |
|
12.4 h EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/19956953 |
100 mg single, intravenous dose: 100 mg route of administration: Intravenous experiment type: SINGLE co-administered: |
ERLOTINIB plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
Funbound
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
7% |
ERLOTINIB plasma | Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
Doses
Dose | Population | Adverse events |
---|---|---|
100 mg 1 times / day single, intravenous Highest studied dose Dose: 100 mg, 1 times / day Route: intravenous Route: single Dose: 100 mg, 1 times / day Sources: |
unhealthy, Median age 54 years n = 6 Health Status: unhealthy Condition: solid tumors Age Group: Median age 54 years Sex: M+F Population Size: 6 Sources: |
|
150 mg 1 times / day multiple, oral Recommended|MTD Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 7 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 7 Sources: |
Other AEs: Mucositis, Diarrhea... Other AEs: Mucositis (grade 1-2, 28.6%) Sources: Diarrhea (grade 1-2, 85.7%) Hyperbilirubinemia (grade 1-2, 14.3%) Skin toxicity (grade 1-2, 28.6%) |
200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 6 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 6 Sources: |
Other AEs: Diarrhea, Hyperbilirubinemia... Other AEs: Diarrhea (grade 1-2, 66.7%) Sources: Hyperbilirubinemia (grade 1-2, 33.3%) Skin toxicity (grade 1-2, 83.3%) Headache (grade 1-2, 33.3%) Diarrhea (grade 4, 33.3%) |
100 mg 1 times / day multiple, oral Recommended Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Co-administed with:: Amrubicin(30 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Other AEs: Neutropenia... |
100 mg 1 times / day multiple, oral Recommended Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Co-administed with:: Amrubicin(35 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Other AEs: Neutropenia, Neutropenia... Other AEs: Neutropenia (grade 3, 33.3%) Sources: Neutropenia (grade 4, 66.7%) Leukopenia (grade 3, 33.3%) Leukopenia (grade 4, 33.3%) |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: Amrubicin(30 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Disc. AE: Leukopenia... Other AEs: Erysipelas, Leukopenia... AEs leading to discontinuation/dose reduction: Leukopenia (grade 3, 33.3%) Other AEs:Erysipelas (grade 3, 33.3%) Sources: Leukopenia (grade 4, 33.3%) Neutropenia (grade 3, 33.3%) Neutropenia (grade 4, 33.3%) |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Disc. AE: Rash, Diarrhea... Other AEs: Rash, Pruritus... AEs leading to discontinuation/dose reduction: Rash (10%) Other AEs:Diarrhea (4%) Rash (7%) Diarrhea (2%) Rash (grade 3, 8%) Sources: Pruritus (grade 3, <1%) Diarrhea (grade 3, 6%) Nausea (grade 3, 3%) Vomiting (grade 3, 2%) Stomatitis (grade 3, <1%) Constipation (grade 3, 1%) Abdominal pain (grade 3, 2%) Fatigue (grade 3, 14%) Chest pain (grade 3, 4%) Dyspnea (grade 3, 17%) Cough (grade 3, 4%) Hemoptysis (grade 3, 1%) Anorexia (grade 3, 8%) Headache (grade 3, 1%) Neuropathy (grade 3, 3%) Bone pain (grade 3, 3%) Infection (grade 3, 4%) Conjunctivitis (grade 3, <1%) Insomnia (grade 3, <1%) Rash (grade 4, <1%) Diarrhea (grade 4, <1%) Anorexia (grade 4, 1%) Fatigue (grade 4, 4%) Dyspnea (grade 4, 11%) Vomiting (grade 4, <1%) Abdominal pain (grade 4, <1%) |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Disc. AE: Diarrhoea, Rash... AEs leading to discontinuation/dose reduction: Diarrhoea (1%) Sources: Rash (1%) |
2000 mg 1 times / week multiple, oral Highest studied dose Dose: 2000 mg, 1 times / week Route: oral Route: multiple Dose: 2000 mg, 1 times / week Sources: |
unhealthy, Median age 63 years n = 19 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 63 years Sex: M+F Population Size: 19 Sources: |
Other AEs: Fatigue, Dehydration... Other AEs: Fatigue (grade 3, 5.3%) Sources: Dehydration (grade 3, 5.3%) Pneumonitis (grade 3, 5.3%) |
200 mg 2 times / day multiple, oral Highest studied dose Dose: 200 mg, 2 times / day Route: oral Route: multiple Dose: 200 mg, 2 times / day Sources: |
healthy, adult n = 6 Health Status: healthy Age Group: adult Sex: M Population Size: 6 Sources: |
Disc. AE: Rash... AEs leading to discontinuation/dose reduction: Rash (grade 3, 100%) Sources: |
1000 mg 1 times / day single, oral Highest studied dose Dose: 1000 mg, 1 times / day Route: oral Route: single Dose: 1000 mg, 1 times / day Sources: |
healthy n = 4 Health Status: healthy Population Size: 4 Sources: |
Other AEs: Erythematous rash... Other AEs: Erythematous rash (grade 1) Sources: |
200 mg 2 times / day multiple, oral Highest studied dose Dose: 200 mg, 2 times / day Route: oral Route: multiple Dose: 200 mg, 2 times / day Sources: |
healthy n = 5 Health Status: healthy Population Size: 5 Sources: |
Other AEs: Diarrhea, Transaminases increased... Other AEs: Diarrhea Sources: Transaminases increased |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
Hyperbilirubinemia | grade 1-2, 14.3% | 150 mg 1 times / day multiple, oral Recommended|MTD Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 7 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 7 Sources: |
Mucositis | grade 1-2, 28.6% | 150 mg 1 times / day multiple, oral Recommended|MTD Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 7 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 7 Sources: |
Skin toxicity | grade 1-2, 28.6% | 150 mg 1 times / day multiple, oral Recommended|MTD Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 7 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 7 Sources: |
Diarrhea | grade 1-2, 85.7% | 150 mg 1 times / day multiple, oral Recommended|MTD Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 7 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 7 Sources: |
Headache | grade 1-2, 33.3% | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 6 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 6 Sources: |
Hyperbilirubinemia | grade 1-2, 33.3% | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 6 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 6 Sources: |
Diarrhea | grade 1-2, 66.7% | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 6 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 6 Sources: |
Skin toxicity | grade 1-2, 83.3% | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 6 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 6 Sources: |
Diarrhea | grade 4, 33.3% | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, Median age 57 years n = 6 Health Status: unhealthy Condition: solid tumors Age Group: Median age 57 years Sex: M+F Population Size: 6 Sources: |
Neutropenia | grade 3, 33.3% | 100 mg 1 times / day multiple, oral Recommended Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Co-administed with:: Amrubicin(30 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Leukopenia | grade 3, 33.3% | 100 mg 1 times / day multiple, oral Recommended Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Co-administed with:: Amrubicin(35 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Neutropenia | grade 3, 33.3% | 100 mg 1 times / day multiple, oral Recommended Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Co-administed with:: Amrubicin(35 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Leukopenia | grade 4, 33.3% | 100 mg 1 times / day multiple, oral Recommended Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Co-administed with:: Amrubicin(35 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Neutropenia | grade 4, 66.7% | 100 mg 1 times / day multiple, oral Recommended Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Co-administed with:: Amrubicin(35 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Erysipelas | grade 3, 33.3% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: Amrubicin(30 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Neutropenia | grade 3, 33.3% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: Amrubicin(30 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Leukopenia | grade 3, 33.3% Disc. AE |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: Amrubicin(30 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Leukopenia | grade 4, 33.3% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: Amrubicin(30 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Neutropenia | grade 4, 33.3% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: Amrubicin(30 mg/m2; Days 1-3) Sources: |
unhealthy, Median age 62 years n = 3 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 3 Sources: |
Rash | 10% Disc. AE |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Diarrhea | 2% Disc. AE |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Diarrhea | 4% Disc. AE |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Rash | 7% Disc. AE |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Constipation | grade 3, 1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Headache | grade 3, 1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Hemoptysis | grade 3, 1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Fatigue | grade 3, 14% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Dyspnea | grade 3, 17% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Abdominal pain | grade 3, 2% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Vomiting | grade 3, 2% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Bone pain | grade 3, 3% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Nausea | grade 3, 3% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Neuropathy | grade 3, 3% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Chest pain | grade 3, 4% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Cough | grade 3, 4% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Infection | grade 3, 4% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Diarrhea | grade 3, 6% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Anorexia | grade 3, 8% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Rash | grade 3, 8% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Conjunctivitis | grade 3, <1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Insomnia | grade 3, <1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Pruritus | grade 3, <1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Stomatitis | grade 3, <1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Anorexia | grade 4, 1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Dyspnea | grade 4, 11% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Fatigue | grade 4, 4% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Abdominal pain | grade 4, <1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Diarrhea | grade 4, <1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Rash | grade 4, <1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Vomiting | grade 4, <1% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Diarrhoea | 1% Disc. AE |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Rash | 1% Disc. AE |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, Median age 62 years n = 485 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 62 years Sex: M+F Population Size: 485 Sources: |
Dehydration | grade 3, 5.3% | 2000 mg 1 times / week multiple, oral Highest studied dose Dose: 2000 mg, 1 times / week Route: oral Route: multiple Dose: 2000 mg, 1 times / week Sources: |
unhealthy, Median age 63 years n = 19 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 63 years Sex: M+F Population Size: 19 Sources: |
Fatigue | grade 3, 5.3% | 2000 mg 1 times / week multiple, oral Highest studied dose Dose: 2000 mg, 1 times / week Route: oral Route: multiple Dose: 2000 mg, 1 times / week Sources: |
unhealthy, Median age 63 years n = 19 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 63 years Sex: M+F Population Size: 19 Sources: |
Pneumonitis | grade 3, 5.3% | 2000 mg 1 times / week multiple, oral Highest studied dose Dose: 2000 mg, 1 times / week Route: oral Route: multiple Dose: 2000 mg, 1 times / week Sources: |
unhealthy, Median age 63 years n = 19 Health Status: unhealthy Condition: nonsmall cell lung cance Age Group: Median age 63 years Sex: M+F Population Size: 19 Sources: |
Rash | grade 3, 100% Disc. AE |
200 mg 2 times / day multiple, oral Highest studied dose Dose: 200 mg, 2 times / day Route: oral Route: multiple Dose: 200 mg, 2 times / day Sources: |
healthy, adult n = 6 Health Status: healthy Age Group: adult Sex: M Population Size: 6 Sources: |
Erythematous rash | grade 1 | 1000 mg 1 times / day single, oral Highest studied dose Dose: 1000 mg, 1 times / day Route: oral Route: single Dose: 1000 mg, 1 times / day Sources: |
healthy n = 4 Health Status: healthy Population Size: 4 Sources: |
Diarrhea | 200 mg 2 times / day multiple, oral Highest studied dose Dose: 200 mg, 2 times / day Route: oral Route: multiple Dose: 200 mg, 2 times / day Sources: |
healthy n = 5 Health Status: healthy Population Size: 5 Sources: |
|
Transaminases increased | 200 mg 2 times / day multiple, oral Highest studied dose Dose: 200 mg, 2 times / day Route: oral Route: multiple Dose: 200 mg, 2 times / day Sources: |
healthy n = 5 Health Status: healthy Population Size: 5 Sources: |
Overview
CYP3A4 | CYP2C9 | CYP2D6 | hERG |
---|---|---|---|
OverviewOther
Other Inhibitor | Other Substrate | Other Inducer |
---|---|---|
Drug as perpetrator
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
yes [IC50 0.93 uM] | ||||
yes [IC50 31 uM] | ||||
yes [IC50 <0.1 uM] | ||||
yes [Ki 10 uM] | ||||
yes [Ki 14.7 uM] | ||||
yes [Ki 20 uM] | ||||
yes [Ki 35.7 uM] | ||||
yes [Ki 44 uM] |
Drug as victim
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
major [Km 5.9 uM] | yes (co-administration study) Comment: Coadministration of erlotinib with ketoconazole, a potent inhibitor of CYP3A4, resulted in a significant (67%) increase in erlotinib exposure (Study NP16612). The CYP3A4 inducer rifampicin has been demonstrated to impact the exposure to erlotinib; in Study NP16638 co-administration led to a 64% reduction in erlotinib AUC. Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-743_Tarceva_biopharmr.PDF#page=10 Page: - |
|||
minor | ||||
no | ||||
no | ||||
no | ||||
yes [Km 24 uM] | ||||
yes | ||||
yes | ||||
yes |
Tox targets
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
PubMed
Title | Date | PubMed |
---|---|---|
Epidermal growth factor receptor tyrosine kinase as a target for anticancer therapy. | 2000 |
|
Substrate competitive inhibitors of IGF-1 receptor kinase. | 2000 Dec 26 |
|
OSI-774 OSI Pharmaceuticals. | 2001 Feb |
|
OSI Pharmaceuticals, Genentech and Roche announce data from clinical studies of Tarceva. | 2001 Jun |
|
Anticancer therapy targeting the erbB family of receptor tyrosine kinases. | 2001 Oct |
|
A novel approach in the treatment of cancer: targeting the epidermal growth factor receptor. | 2001 Oct |
|
HER-targeted tyrosine-kinase inhibitors. | 2002 |
|
Effects of the epidermal growth factor receptor inhibitor OSI-774, Tarceva, on downstream signaling pathways and apoptosis in human pancreatic adenocarcinoma. | 2002 Aug |
|
[New therapeutic targets and strategies in lung cancer]. | 2002 Aug |
|
Gateways to clinical trials. | 2002 Dec |
|
[Molecular target-based cancer therapy: epidermal growth factor receptor inhibitors]. | 2002 Feb |
|
Targeting epidermal growth factor receptor in lung cancer. | 2002 Jul |
|
Tyrosine kinase signal transduction inhibitors. Clinical trials. | 2002 Jul-Aug |
|
The epidermal growth factor receptor: a new target for anticancer therapy. | 2002 May-Jun |
|
Structure of the epidermal growth factor receptor kinase domain alone and in complex with a 4-anilinoquinazoline inhibitor. | 2002 Nov 29 |
|
Epithelial growth factor receptor interacting agents. | 2002 Oct |
|
Cancer drugs. Smart weapons prove tough to design. | 2002 Oct 18 |
|
Erlotinib OSI/Roche/Genentech. | 2002 Sep |
|
Small-molecule epidermal growth factor receptor tyrosine kinase inhibitors. | 2003 |
|
Erlotinib: a new therapeutic approach for non-small cell lung cancer. | 2003 Aug |
|
Clinical studies with non-iressa EGFR tyrosine kinase inhibitors. | 2003 Aug |
|
For investigational targeted drugs, combination trials pose challenges. | 2003 Dec 3 |
|
Phase I studies of ZD1839 in patients with common solid tumors. | 2003 Feb |
|
Epidermal growth factor receptor as a therapeutic target in colorectal cancer. | 2003 Feb |
|
[Molecular-targeted therapy]. | 2003 Feb |
|
[Molecular targetting therapy for non-small-cell lung neoplasms with EGF-R inhibitors]. | 2003 Feb 10 |
|
Pharmacodynamic evaluation of the epidermal growth factor receptor inhibitor OSI-774 in human epidermis of cancer patients. | 2003 Jul |
|
[Non-small cell lung cancer: 1) Molecular-target therapy]. | 2003 Jul 10 |
|
Epidermal growth factor receptor inhibitors: an update on their development as cancer therapeutics. | 2003 Jun |
|
Challenges and opportunities for Erlotinib (Tarceva): what does the future hold? | 2003 Jun |
|
Identifying predictive and surrogate markers of erlotinib antitumor activity other than rash. | 2003 Nov |
|
Can rash associated with HER1/EGFR inhibition be used as a marker of treatment outcome? | 2003 Nov |
|
Targeting the HER1/EGFR receptor to improve outcomes in non-small-cell lung cancer. | 2003 Nov |
|
Gateways to clinical trials. | 2003 Oct |
|
Liquid-chromatographic determination of erlotinib (OSI-774), an epidermal growth factor receptor tyrosine kinase inhibitor. | 2003 Oct 25 |
|
Gateways to clinical trials. | 2003 Sep |
|
Potential role for epidermal growth factor receptor inhibitors in combined-modality therapy for non-small-cell lung cancer. | 2004 |
|
Emerging roles of targeted small molecule protein-tyrosine kinase inhibitors in cancer therapy. | 2004 |
|
Gateways to clinical trials. | 2004 Apr |
|
Epidermal growth factor receptor tyrosine kinase inhibitors: evolving role in the treatment of solid tumors. | 2004 Apr |
|
Multicenter phase II study of erlotinib, an oral epidermal growth factor receptor tyrosine kinase inhibitor, in patients with recurrent or metastatic squamous cell cancer of the head and neck. | 2004 Jan 1 |
|
Gateways to clinical trials. | 2004 Jan-Feb |
|
Antitumor activity of erlotinib (OSI-774, Tarceva) alone or in combination in human non-small cell lung cancer tumor xenograft models. | 2004 Jun |
|
[Bronchioloalveolar carcinoma (BAC)]. | 2004 Mar |
|
Inverse correlation of epidermal growth factor receptor messenger RNA induction and suppression of anchorage-independent growth by OSI-774, an epidermal growth factor receptor tyrosine kinase inhibitor, in glioblastoma multiforme cell lines. | 2004 Mar |
|
Emerging role of epidermal growth factor receptor inhibition in therapy for advanced malignancy: focus on NSCLC. | 2004 Mar 1 |
|
New cytotoxic and molecular-targeted therapies of head and neck tumors. | 2004 May |
Sample Use Guides
The dose for NSCLC is 150 mg/day.
The dose for pancreatic cancer is 100 mg/day.
All doses of TARCEVA should be taken on an empty stomach at least
one hour before or two hours after food
Route of Administration:
Oral
In Vitro Use Guide
Sources: https://www.ncbi.nlm.nih.gov/pubmed/26951976
Erlotinib (20 µM) inhibited 33.8% of the growth of T. gondii
Substance Class |
Chemical
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Record UNII |
J4T82NDH7E
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NCI_THESAURUS |
C2167
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NDF-RT |
N0000175605
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L01XE03
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LIVERTOX |
NBK548407
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NCI_THESAURUS |
C129825
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N0000175076
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EMA ASSESSMENT REPORTS |
TARCEVA (AUTHORIZED: PANCREATIC NEOPLASMS)
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EMA ASSESSMENT REPORTS |
TARCEVA (AUTHORISED: CARCINOMA, NON-SMALL-CELL LUNG)
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Erlotinib
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ERLOTINIB
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MAJOR
FECAL; URINE
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METABOLITE -> PARENT |
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METABOLITE -> PARENT |
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METABOLITE -> PARENT |
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FECAL; URINE
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METABOLITE -> PARENT |
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METABOLITE ACTIVE -> PARENT |
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ACTIVE MOIETY |
Name | Property Type | Amount | Referenced Substance | Defining | Parameters | References |
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CSF/PLASMA RATIO | BIOLOGICAL |
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SPECIES BIOLOGICAL |
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