NCT03635489

A Study of the Efficacy and Safety of Bevacizumab in Chinese Women With Newly Diagnosed, Previously Untreated Stage III or Stage IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin Paclitaxel Plus Concurrent and Extended Bevacizumab in Chinese Women With Newly Diagnosed, Previously Untreated, Stage III or Stage IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, double-blind, 2-arm, randomized study will evaluate the efficacy and safety of bevacizumab plus paclitaxel and caboplatin compared with placebo plus paclitaxel and caboplatin in Chinese participants with newly diagnosed, previously untreated Stage III or Stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants whose disease has not progressed after six cycles of paclitaxel and carboplatin with either bevacizumab or placebo will continue treatment with either bevacizumab or placebo until disease progression, unacceptable toxicity, or a maximum of 22 cycles, whichever occurs first.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	175 mg/m\^2 IV infusion on Day 1 of each 21-day cycle.
DRUG	Bevacizumab	15 mg/kg IV infusion on Day 1 of each 21-day cycle.
DRUG	Carboplatin	Area Under the Curve (AUC) of 6 mg/ml/min on Day 1 of each 21-day cycle.
DRUG	Placebo	Placebo matched to bevacizumab IV infusion on Day 1 of each 21-day cycle.

Timeline

• Start date: 2018-08-15
• Primary completion: 2021-05-26
• Completion: 2023-05-11
• First posted: 2018-08-17
• Last updated: 2024-10-03
• Results posted: 2023-03-17

Locations

16 sites across 1 country: China