Details
Stereochemistry | ABSOLUTE |
Molecular Formula | C23H23N3O5 |
Molecular Weight | 421.4458 |
Optical Activity | UNSPECIFIED |
Defined Stereocenters | 1 / 1 |
E/Z Centers | 0 |
Charge | 0 |
SHOW SMILES / InChI
SMILES
CC[C@@]1(O)C(=O)OCC2=C1C=C3N(CC4=C3N=C5C=CC(O)=C(CN(C)C)C5=C4)C2=O
InChI
InChIKey=UCFGDBYHRUNTLO-QHCPKHFHSA-N
InChI=1S/C23H23N3O5/c1-4-23(30)16-8-18-20-12(9-26(18)21(28)15(16)11-31-22(23)29)7-13-14(10-25(2)3)19(27)6-5-17(13)24-20/h5-8,27,30H,4,9-11H2,1-3H3/t23-/m0/s1
Molecular Formula | C23H23N3O5 |
Molecular Weight | 421.4458 |
Charge | 0 |
Count |
|
Stereochemistry | ABSOLUTE |
Additional Stereochemistry | No |
Defined Stereocenters | 1 / 1 |
E/Z Centers | 0 |
Optical Activity | UNSPECIFIED |
DescriptionSources: http://www.drugbank.ca/drugs/DB01030Curator's Comment: Description was created based on several sources, including
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020671s021lbl.pdf
Sources: http://www.drugbank.ca/drugs/DB01030
Curator's Comment: Description was created based on several sources, including
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020671s021lbl.pdf
Topotecan, a semi-synthetic derivative of camptothecin (a plant alkaloid obtained from the Camptotheca acuminata tree), is an anti-tumor drug with topoisomerase I-inhibitory activity similar to irinotecan. DNA topoisomerases are enzymes in the cell nucleus that regulate DNA topology (3-dimensional conformation) and facilitate nuclear processes such as DNA replication, recombination, and repair. During these processes, DNA topoisomerase I creates reversible single-stranded breaks in double-stranded DNA, allowing intact single DNA strands to pass through the break and relieve the topologic constraints inherent in supercoiled DNA. The 3'-DNA terminus of the broken DNA strand binds covalently with the topoisomerase enzyme to form a catalytic intermediate called a cleavable complex. After DNA is sufficiently relaxed and the strand passage reaction is complete, DNA topoisomerase reattaches the broken DNA strands to form the unaltered topoisomers that allow transcription to proceed. Topotecan interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells can be affected by the medicine, other effects may also occur. Unlike irinotecan, topotecan is found predominantly in the inactive carboxylate form at neutral pH and it is not a prodrug. Topotecan has the same mechanism of action as irinotecan and is believed to exert its cytotoxic effects during the S-phase of DNA synthesis. Topoisomerase I relieves torsional strain in DNA by inducing reversible single strand breaks. Topotecan binds to the topoisomerase I-DNA complex and prevents religation of these single strand breaks. This ternary complex interferes with the moving replication fork, which leads to the induction of replication arrest and lethal double-stranded breaks in DNA. As mammalian cells cannot efficiently repair these double strand breaks, the formation of this ternary complex eventually leads to apoptosis (programmed cell death). Topotecan mimics a DNA base pair and binds at the site of DNA cleavage by intercalating between the upstream (−1) and downstream (+1) base pairs. Intercalation displaces the downstream DNA, thus preventing religation of the cleaved strand. By specifically binding to the enzyme–substrate complex, Topotecan acts as an uncompetitive inhibitor. Topotecan is used for the treatment of advanced ovarian cancer in patients with disease that has recurred or progressed following therapy with platinum-based regimens. Also used as a second-line therapy for treatment-sensitive small cell lung cancer, as well as in combination with cisplatin for the treatment of stage IV-B, recurrent, or persistent cervical cancer not amenable to curative treatment with surgery and/or radiation therapy. Topotecan is sold under the trade name Hycamtin.
CNS Activity
Sources: https://www.ncbi.nlm.nih.gov/pubmed/14755016
Curator's Comment: freely crosses the blood-brain barrier
Originator
Approval Year
Targets
Primary Target | Pharmacology | Condition | Potency |
---|---|---|---|
Target ID: CHEMBL1781 Sources: http://www.drugbank.ca/drugs/DB01030 |
1028.0 nM [IC50] | ||
Target ID: CHEMBL392 Sources: https://www.ncbi.nlm.nih.gov/pubmed/21463912 |
3.16 µM [IC50] | ||
Target ID: CHEMBL614697 Sources: https://www.ncbi.nlm.nih.gov/pubmed/21463912 |
0.448 µM [IC50] | ||
Target ID: CHEMBL394 Sources: https://www.ncbi.nlm.nih.gov/pubmed/21463912 |
1.1 µM [IC50] | ||
Target ID: DNA |
|||
Target ID: CHEMBL384 Sources: https://www.ncbi.nlm.nih.gov/pubmed/8182764 |
33.0 nM [IC50] |
Conditions
Condition | Modality | Targets | Highest Phase | Product |
---|---|---|---|---|
Primary | HYCAMTIN Approved UseHYCAMTIN for injection is a topoisomerase inhibitor indicated for:
• metastatic carcinoma of the ovary after disease progression on or after initial or subsequent chemotherapy.
• small cell lung cancer platinum-sensitive disease in patients who progressed after first-line chemotherapy.
• combination therapy with cisplatin for Stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment. Launch Date1996 |
|||
Primary | HYCAMTIN Approved UseHYCAMTIN for injection is a topoisomerase inhibitor indicated for:
• metastatic carcinoma of the ovary after disease progression on or after initial or subsequent chemotherapy.
• small cell lung cancer platinum-sensitive disease in patients who progressed after first-line chemotherapy.
• combination therapy with cisplatin for Stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment. Launch Date1996 |
Cmax
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
6.1 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/25677219/ |
2.3 mg/m² single, oral dose: 2.3 mg/m² route of administration: Oral experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: FASTED |
|
7.9 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/25677219/ |
2.3 mg/m² single, oral dose: 2.3 mg/m² route of administration: Oral experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: FASTED |
|
9.29 ng/mL EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/26291057 |
4 mg single, oral dose: 4 mg route of administration: Oral experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
AUC
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
210.5 nM × h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/8070027/ |
1.25 mg/m² single, intravenous dose: 1.25 mg/m² route of administration: Intravenous experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
|
262.7 nM × h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/8070027/ |
1.5 mg/m² single, intravenous dose: 1.5 mg/m² route of administration: Intravenous experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
|
304.3 nM × h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/8070027/ |
2 mg/m² single, intravenous dose: 2 mg/m² route of administration: Intravenous experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
|
379.6 nM × h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/8070027/ |
1.75 mg/m² single, intravenous dose: 1.75 mg/m² route of administration: Intravenous experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
|
49.3 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/25677219/ |
2.3 mg/m² single, oral dose: 2.3 mg/m² route of administration: Oral experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: FASTED |
|
60.7 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/25677219/ |
2.3 mg/m² single, oral dose: 2.3 mg/m² route of administration: Oral experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: FASTED |
|
61 ng × h/mL EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/26291057 |
4 mg single, oral dose: 4 mg route of administration: Oral experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
T1/2
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
3 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/8070027/ |
1.25 mg/m² single, intravenous dose: 1.25 mg/m² route of administration: Intravenous experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
|
3.7 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/8070027/ |
1.5 mg/m² single, intravenous dose: 1.5 mg/m² route of administration: Intravenous experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
|
3.7 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/8070027/ |
2 mg/m² single, intravenous dose: 2 mg/m² route of administration: Intravenous experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
|
3.5 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/8070027/ |
1.75 mg/m² single, intravenous dose: 1.75 mg/m² route of administration: Intravenous experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
|
6 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/25677219/ |
2.3 mg/m² single, oral dose: 2.3 mg/m² route of administration: Oral experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: FASTED |
|
5.6 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/25677219/ |
2.3 mg/m² single, oral dose: 2.3 mg/m² route of administration: Oral experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: FASTED |
|
5.23 h EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/26291057 |
4 mg single, oral dose: 4 mg route of administration: Oral experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
Funbound
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
22.2% EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/25677219/ |
2.3 mg/m² single, oral dose: 2.3 mg/m² route of administration: Oral experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: FASTED |
|
14.8% EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/25677219/ |
2.3 mg/m² single, oral dose: 2.3 mg/m² route of administration: Oral experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: FASTED |
|
65% |
TOPOTECAN plasma | Homo sapiens |
Doses
Dose | Population | Adverse events |
---|---|---|
10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Other AEs: Leukopenia, Leukopenia... Other AEs: Leukopenia (grade 1, 1 patient) Sources: Leukopenia (grade 2, 1 patient) Leukopenia (grade 3, 7 patients) Leukopenia (grade 4, 2 patients) Neutropenia (grade 2, 6 patients) Neutropenia (grade 3, 2 patients) Neutropenia (grade 4, 1 patient) Thrombocytopenia (grade 1, 2 patients) Thrombocytopenia (grade 2, 1 patient) Thrombocytopenia (grade 3, 1 patient) Thrombocytopenia (grade 4, 2 patients) Anemia (grade 1, 3 patients) Anemia (grade 2, 3 patients) Anemia (1 patient) |
8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Other AEs: Leukopenia, Leukopenia... Other AEs: Leukopenia (grade 1, 4 patients) Sources: Leukopenia (grade 2, 4 patients) Leukopenia (grade 3, 3 patients) Leukopenia (grade 4, 1 patient) Neutropenia (grade 1, 1 patient) Neutropenia (grade 2, 2 patients) Neutropenia (grade 3, 1 patient) Neutropenia (grade 4, 1 patient) Thrombocytopenia (grade 2, 3 patients) Thrombocytopenia (grade 3, 2 patients) Anemia (grade 1, 4 patients) Anemia (grade 2, 1 patient) Anemia (grade 3, 1 patient) Anemia (3 patients) |
2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Other AEs: Leukopenia, Leukopenia... Other AEs: Leukopenia (grade 3, 40.7%) Sources: Leukopenia (grade 4, 15.9%) Neutropenia (grade 3, 31%) Neutropenia (grade 4, 50.4%) Thrombocytopenia (grade 3, 17.7%) Thrombocytopenia (grade 4, 22.1%) Anemia (grade 3, 26.5%) Anemia (grade 4, 2.7%) Nausea (grade 1, 31.9%) Nausea (grade 2, 25%) Nausea (grade 3, 5.2%) Alopecia (grade 1, 19.8%) Alopecia (grade 2, 22.4%) Alopecia (grade 3, 4.3%) Fatigue (grade 1, 22.4%) Fatigue (grade 2, 10.3%) Fatigue (grade 3, 5.2%) Vomiting (grade 1, 12.1%) Vomiting (grade 2, 19.8%) Vomiting (grade 3, 4.3%) Vomiting (grade 4, 0.9%) Diarrhea (grade 1, 19%) Diarrhea (grade 2, 13.8%) Diarrhea (grade 3, 1.7%) Diarrhea (grade 4, 0.9%) |
1.5 mg/m2 1 times / day multiple, intravenous Recommended Dose: 1.5 mg/m2, 1 times / day Route: intravenous Route: multiple Dose: 1.5 mg/m2, 1 times / day Sources: |
unhealthy, adult |
Other AEs: Neutropenia... |
1.5 mg/m2 1 times / day multiple, intravenous Recommended Dose: 1.5 mg/m2, 1 times / day Route: intravenous Route: multiple Dose: 1.5 mg/m2, 1 times / day Sources: |
unhealthy, adult |
Other AEs: Thrombocytopenia, Anemia... Other AEs: Thrombocytopenia (grade 4, 20%) Sources: Anemia (grade 3-4, 11%) |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
Anemia | 1 patient | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Leukopenia | grade 1, 1 patient | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Thrombocytopenia | grade 1, 2 patients | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Anemia | grade 1, 3 patients | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Leukopenia | grade 2, 1 patient | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Thrombocytopenia | grade 2, 1 patient | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Anemia | grade 2, 3 patients | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Neutropenia | grade 2, 6 patients | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Thrombocytopenia | grade 3, 1 patient | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Neutropenia | grade 3, 2 patients | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Leukopenia | grade 3, 7 patients | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Neutropenia | grade 4, 1 patient | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Leukopenia | grade 4, 2 patients | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Thrombocytopenia | grade 4, 2 patients | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Anemia | 3 patients | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Neutropenia | grade 1, 1 patient | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Anemia | grade 1, 4 patients | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Leukopenia | grade 1, 4 patients | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Anemia | grade 2, 1 patient | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Neutropenia | grade 2, 2 patients | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Thrombocytopenia | grade 2, 3 patients | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Leukopenia | grade 2, 4 patients | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Anemia | grade 3, 1 patient | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Neutropenia | grade 3, 1 patient | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Thrombocytopenia | grade 3, 2 patients | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Leukopenia | grade 3, 3 patients | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Leukopenia | grade 4, 1 patient | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Neutropenia | grade 4, 1 patient | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) Health Status: unhealthy Age Group: 54 years (range: 34-75 years) Sex: M+F Sources: |
Vomiting | grade 1, 12.1% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Diarrhea | grade 1, 19% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Alopecia | grade 1, 19.8% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Fatigue | grade 1, 22.4% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Nausea | grade 1, 31.9% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Fatigue | grade 2, 10.3% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Diarrhea | grade 2, 13.8% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Vomiting | grade 2, 19.8% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Alopecia | grade 2, 22.4% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Nausea | grade 2, 25% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Diarrhea | grade 3, 1.7% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Thrombocytopenia | grade 3, 17.7% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Anemia | grade 3, 26.5% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Neutropenia | grade 3, 31% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Alopecia | grade 3, 4.3% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Vomiting | grade 3, 4.3% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Leukopenia | grade 3, 40.7% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Fatigue | grade 3, 5.2% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Nausea | grade 3, 5.2% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Diarrhea | grade 4, 0.9% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Vomiting | grade 4, 0.9% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Leukopenia | grade 4, 15.9% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Anemia | grade 4, 2.7% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Thrombocytopenia | grade 4, 22.1% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Neutropenia | grade 4, 50.4% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) Health Status: unhealthy Age Group: 62.1 years (range: 38-86 years) Sex: F Sources: |
Neutropenia | grade 4, 58% | 1.5 mg/m2 1 times / day multiple, intravenous Recommended Dose: 1.5 mg/m2, 1 times / day Route: intravenous Route: multiple Dose: 1.5 mg/m2, 1 times / day Sources: |
unhealthy, adult |
Anemia | grade 3-4, 11% | 1.5 mg/m2 1 times / day multiple, intravenous Recommended Dose: 1.5 mg/m2, 1 times / day Route: intravenous Route: multiple Dose: 1.5 mg/m2, 1 times / day Sources: |
unhealthy, adult |
Thrombocytopenia | grade 4, 20% | 1.5 mg/m2 1 times / day multiple, intravenous Recommended Dose: 1.5 mg/m2, 1 times / day Route: intravenous Route: multiple Dose: 1.5 mg/m2, 1 times / day Sources: |
unhealthy, adult |
PubMed
Title | Date | PubMed |
---|---|---|
Phase II study of oral topotecan in advanced non-small cell lung cancer. | 2000 Mar |
|
Developmental chemotherapy in advanced ovarian cancer: incorporation of topoisomerase-I inhibitors and perspective of the Gynecologic Oncology Group. | 2001 |
|
Treatment of extensive stage small cell lung cancer. | 2001 |
|
Effect of hemodialysis on topotecan disposition in a patient with severe renal dysfunction. | 2001 |
|
Paclitaxel-based three-drug combinations for the treatment of small cell lung cancer: a review of the Sarah Cannon Cancer Center experience. | 2001 Apr |
|
Antitumor activity of XR5944, a novel and potent topoisomerase poison. | 2001 Apr |
|
Radiosensitization of tumor-targeted radioimmunotherapy with prolonged topotecan infusion in human breast cancer xenografts. | 2001 Apr 1 |
|
Unusual potency of BN 80915, a novel fluorinated E-ring modified camptothecin, toward human colon carcinoma cells. | 2001 Apr 1 |
|
Subcellular localization and distribution of the breast cancer resistance protein transporter in normal human tissues. | 2001 Apr 15 |
|
Topotecan given as a 21-day infusion in the treatment of advanced ovarian cancer. | 2001 Apr 20 |
|
A novel 7-modified camptothecin analog overcomes breast cancer resistance protein-associated resistance in a mitoxantrone-selected colon carcinoma cell line. | 2001 Aug 15 |
|
Clear cell carcinoma of the ovary: a remarkable case. | 2001 Feb |
|
Lack of efficacy of topotecan in the treatment of metastatic or recurrent squamous carcinoma of the head and neck: an Eastern Cooperative Oncology Group Trial (E3393). | 2001 Feb |
|
Topotecan concomitant with primary brachytherapy radiation in patients with cervical carcinoma: a phase I trial. | 2001 Feb |
|
P73a overexpression is associated with resistance to treatment with DNA-damaging agents in a human ovarian cancer cell line. | 2001 Feb 1 |
|
P53 modulates the effect of loss of DNA mismatch repair on the sensitivity of human colon cancer cells to the cytotoxic and mutagenic effects of cisplatin. | 2001 Feb 15 |
|
The effect of increasing topotecan infusion from 30 minutes to 4 hours on the duration of exposure in cerebrospinal fluid. | 2001 Jan |
|
Overexpression of the ATP-binding cassette half-transporter, ABCG2 (Mxr/BCrp/ABCP1), in flavopiridol-resistant human breast cancer cells. | 2001 Jan |
|
Paclitaxel plus topotecan treatment for patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. | 2001 Jul |
|
Advances in the management of epithelial ovarian cancer. | 2001 Jul |
|
Effective dosing of topotecan with carboplatin in relapsed ovarian cancer: a phase I/II study. | 2001 Jul 1 |
|
CCNU-dependent potentiation of TRAIL/Apo2L-induced apoptosis in human glioma cells is p53-independent but may involve enhanced cytochrome c release. | 2001 Jul 12 |
|
Overview of the treatment of infant central nervous system tumors: medulloblastoma as a model. | 2001 Jun-Jul |
|
Carrier and dose effects on the pharmacokinetics of T-0128, a camptothecin analogue-carboxymethyl dextran conjugate, in non-tumor- and tumor-bearing rats. | 2001 Mar 12 |
|
Synthesis and biological evaluation of novel A-ring modified hexacyclic camptothecin analogues. | 2001 May 10 |
|
High-dose topotecan, melphalan, and cyclophosphamide (TMC) with stem cell support: a new regimen for the treatment of advanced ovarian cancer. | 2001 Sep |
|
Body-surface area-based dosing does not increase accuracy of predicting cisplatin exposure. | 2001 Sep 1 |
Sample Use Guides
Ovarian cancer and small cell lung cancer: 1.5 mg/m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day course.
Cervical cancer: 0.75 mg/m2 by intravenous infusion over 30 minutes on Days 1, 2, and 3 repeated every 21 days in combination with cisplatin 50 mg/m2 on Day 1
Route of Administration:
Intravenous
In Vitro Use Guide
Sources: https://www.ncbi.nlm.nih.gov/pubmed/8603419
In DC3F hamster lung fibroblasts, 2.5 uM topotecan caused redistribution of topo I to nonnucleolar regions of the nucleus.
Substance Class |
Chemical
Created
by
admin
on
Edited
Mon Mar 31 17:59:15 GMT 2025
by
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on
Mon Mar 31 17:59:15 GMT 2025
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Record UNII |
7M7YKX2N15
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Validated (UNII)
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WHO-VATC |
QL01XX17
Created by
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EMA ASSESSMENT REPORTS |
POTACTASOL (AUTHORISED: SMALL CELL LUNG CARCINOMA, UTERINE CERVICAL NEOPLASMS)
Created by
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FDA ORPHAN DRUG |
694519
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EMA ASSESSMENT REPORTS |
HYCAMTIN (AUTHORIZED: OVARIAN NEOPLASMS, SMALL CELL LUNG CARCINOMA, UTERINE CERVICAL NEOPLASMS)
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EMA ASSESSMENT REPORTS |
EVOTOPIN (WITHDRAWN: OVARIAN NEOPLASMS
Created by
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LIVERTOX |
NBK548037
Created by
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EMA ASSESSMENT REPORTS |
TOPOTECAN HOSPIRA (AUTHORISED: SMALL CELL LUNG CARCINOMA)
Created by
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EMA ASSESSMENT REPORTS |
TOPOTECAN ACTAVIS (AUTHORISED: SMALL CELL LUNG CARCINOMA, UTERINE NEOPLASMS )
Created by
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NDF-RT |
N0000000176
Created by
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EMA ASSESSMENT REPORTS |
TOPOTECAN TEVA (AUTHORIZED: OVARIAN NEOPLASMS, SMALL CELL LUNG CARCINOMA, UTERINE CERVICAL NEOPLASMS)
Created by
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NDF-RT |
N0000175609
Created by
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WHO-ATC |
L01XX17
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NCI_THESAURUS |
C2843
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2707
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7M7YKX2N15
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63632
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6783
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C1413
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8213
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Topotecan
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m10977
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DB01030
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641007
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7101
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SUB11191MIG
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609699
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CHEMBL84
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Topotecan
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57308
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100000089213
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D019772
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123948-87-8
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7M7YKX2N15
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DTXSID3042685
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Vmax
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TRANSPORTER -> SUBSTRATE |
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METABOLITE LESS ACTIVE -> PARENT | |||
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METABOLITE ACTIVE -> PARENT | |||
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METABOLITE -> PARENT |
Topotecan-O-glucuronide and N-desmethyl topotecan-O-glucuronide, were less than 2% of the administered dose.
URINE
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METABOLITE -> PARENT |
FECAL; PLASMA; URINE
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METABOLITE -> PARENT |
URINE
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