NCT03901118

Chiauranib in Combination With Chemotherapy in Patients With Ovarian Cancer

A Multi-center, Phase Ⅱ Clinical Trial of Chiauranib Plus Chemotherapy in Relapsed/Refractory Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Chipscreen Biosciences, Ltd. · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial will evaluate the efficacy and safety of chiauranib added to chemotherapy in patients with relapsed or refractory ovarian cancer, in the meantime, explore the pharmacokinetics characteristic after the combined treatment.

Detailed description

This clinical trial will evaluate the efficacy and safety include adverse events, vital signs, laboratory tests, etc., of chiauranib added to chemotherapy (Paclitaxel/Etoposide) in patients with relapsed or refractory epithelial ovarian, fallopian tube or primary peritoneal cancer, in the meantime, explore the pharmacokinetics characteristic after the combined treatment.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	chiauranib	in the phase of pilot trial, 25mg orally once daily; in the formal phase, 50mg orally once daily
DRUG	etoposide	50mg orally once daily for 21 days, 7 days off, every 28 days for a cycle, 6 cycles at most
DRUG	paclitaxel	60mg/m2, i.v infusion on day 1, 8 and 15, every 21 days for a cycle, 6 cycles at most

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-12-18
• Completion: 2020-12-18
• First posted: 2019-04-03
• Last updated: 2021-03-19

Locations

1 site across 1 country: China