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

Sponsor
Hoffmann-La Roche
Study ID
NCT03635489
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 17, 2018
Start date
Aug 15, 2018
Status verified
Jun 2024
Primary completion
May 26, 2021
Completion
May 11, 2023

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab + Paclitaxel + Carboplatin
    Participants will receive paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion will start at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
  • Placebo Comparator: Placebo + Paclitaxel + Carboplatin
    Participants will receive paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion will start at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months) ]

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