NCT04029909

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

A Phase I Clinical Study of Gimatecan (ST 1481) in Patients With Platinum-resistant or Sensitive Relapsing/Refractory Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The clinical trial is used the traditional 3 +3 design and conducted in two dose groups, 0.6mg/m2/d and 0.8mg/m2/d, with an improved dose escalation design. The initial dose is 0.6mg/m2, once a day for 5 consecutive days, every 28 days for a course of treatment. Subjects are assigned to the corresponding dose group according to the order of enrolling. DLT is observed within 28 days of the first dose of Gimatecan. In the absence of DLT as prescribed by the protocol, the next dose group is started until the maximum tolerated dose (MTD) is observed.

Conditions

• Ovarian Epithelial Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	Gimatecan 0.6mg/m2/d	0.6mg/m2/d for once a day for 5 consecutive days of Gimatecan
DRUG	0.8mg/m2/d	0.8mg/m2/d for once a day for 5 consecutive days of Gimatecan
DRUG	0.4mg/m2/d	0.4mg/m2/d for once a day for 5 consecutive days of Gimatecan

Timeline

• Start date: 2019-07-11
• Primary completion: 2019-12-01
• Completion: 2022-12-01
• First posted: 2019-07-23
• Last updated: 2019-07-23

Locations

1 site across 1 country: China