drugset
drugset / Trial / NCT04029909

A Clinical Study of Gimatecan in Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer

NCT04029909 ↗

Phase 1 Unknown 12 enrolled Lee's Pharmaceutical Limited
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a Phase 1, open-label, dose-escalation ,and multidose study, aiming to investigate the safety, tolerability and pharmacokinetics of Gimatecan in Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer. To explore the dose-limiting toxicity (DLT) and the maximum tolerable dose (MTD) of oral administration of Gimatecan capsules 5 consecutive days, every 28 days.

Timeline

Start
2019-07-11
Primary completion
2019-12
Completion
2022-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Gimatecan Small molecule 0.4 mg/m2 Oral
Subject Gimatecan Small molecule 0.6 mg/m2 Oral
Subject Gimatecan Small molecule 0.8 mg/m2 Oral

Indications

fallopian tube cancer malignant epithelial tumor of ovary primary peritoneal carcinoma