Topotecan: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Topotecan appears in the FDA drug-label database. Marketed as Topotecan.
- Drug class
- Topoisomerase Inhibitor (FDA established pharmacologic class)
- Mechanism of action
- Topoisomerase Inhibitors (as stated on the FDA label)
- Boxed warning
- The FDA label for Topotecan carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Topotecan Injection is indicated for the treatment of: small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the Phase 3 study) or at least 90 days (in the Phase 2 studies) after chemotherapy [see Clinical Studies ( 14 ) ] . Topotecan Injection in combination with cisplatin is indicated for the treatment of: stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy. Topotecan is a topoisomerase inhibitor indicated for: small cell lung cancer sensitive disease after failure of first-line chemotherapy. ( 1 ) combination therapy with cisplatin for stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy. ( 1 )
Phase breakdown
Conditions being studied
Recruiting trials involving Topotecan
- A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)
- A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
- A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
- A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)
- A Study to Evaluate Adverse Events and Change in Disease Activity of Intravenous ABBV-706 Versus Standard of Care in Adult Participants With Relapsed/Refractory Small Cell Lung Cancer
- ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer
- Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer
- Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC
- Study Comparing ZG006 With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer
- Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer
- Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer
- Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
Common questions
Is Topotecan FDA-approved?
Yes, marketed as Topotecan. Its FDA label carries a boxed warning.
How many recruiting trials involve Topotecan?
12 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.