NCT05325229

A Study of Docetaxel for Injection (Albumin-bound) in Combination With Bevacizumab in Patients With Ovarian Cancer

A Single-arm, Multicenter, Phase II Clinical Study of Docetaxel for Injection (Albumin-bound) in Combination With Bevacizumab in Patients With Platinum-Resistant Recurrent Ovarian Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

This trial is a single-arm, multicenter clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) combined with Bevacizumab and the pharmacokinetic characteristics of Docetaxel in patients with platinum-resistant recurrent ovarian cancer.

Detailed description

This study will be conducted in two stages (dose escalation trial and phase II trial). Dose escalation trial: To explore the safety and tolerability of Docetaxel for Injection (Albumin-bound) (75 mg/m\^2 and 100 mg/m\^2) combined with Bevacizumab 15 mg/kg. Dose escalation will be started at low dose and proceed in turn. Phase II trial: According to the recommended phase II dose (RP2D) determined in the dose escalation trial, a phase II study of Docetaxel for Injection (Albumin-bound) combined with Bevacizumab will be conducted to observe the efficacy of the combination regimen, with overall response rate (ORR) as the primary study endpoint. Simon's optimal 2-stage design will be adopted for phase II study.

Conditions

• Platinum-resistant Recurrent Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel for injection (Albumin-bound)	Docetaxel for injection (Albumin-bound), by intravenous infusion，75 mg/m\^2 or 100 mg/m\^2 once every 3 weeks.
DRUG	Bevacizumab	Bevacizumab, by intravenous infusion, 15 mg/kg once every 3 weeks.

Timeline

• Start date: 2022-08-18
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-04-13
• Last updated: 2022-10-13

Locations

1 site across 1 country: China