A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

PHASE2CompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

December 12, 2017

Primary Completion Date

December 24, 2020

Study Completion Date

July 12, 2024

Conditions
Ovarian Neoplasms
Interventions
DRUG

Niraparib

Niraparib will be administered orally once a day continuously throughout each 21 day cycle (84-day cycle after amendment 2). The starting dose of niraparib will be based on the participant's Baseline actual body weight or platelet count. Participants with a Baseline actual body weight of greater than equal to (\>=) 77 kg and Baseline platelet count of \>=150,000/ microliter (μL) will take 300 mg/day (3X100mg) at each dose administration. Participants with a Baseline actual body weight of less than (\<) 77 kg and/or Baseline platelet count of \<150,000/μL will take 200 mg (2X100 mg) at each dose administration.

BIOLOGICAL

Bevacizumab

Maintenance bevacizumab 15 mg/kg will be administered via a 30-minute IV infusion on Day 1 of every 21-day cycle in the absence of progressive disease (PD), unacceptable toxicity, participant withdrawal, Investigator's decision, or death. Bevacizumab will be administered for up to 10 months during the maintenance phase or up to a total of 15 months inclusive of approximately 5 months of bevacizumab received with chemotherapy.

Trial Locations (29)

12208

GSK Investigational Site, Albany

14642

GSK Investigational Site, Rochester

15224

GSK Investigational Site, Pittsburgh

28816

GSK Investigational Site, Asheville

33705

GSK Investigational Site, St. Petersburg

33908

GSK Investigational Site, Fort Myers

36604

GSK Investigational Site, Mobile

37203

GSK Investigational Site, Nashville

37403

GSK Investigational Site, Chattanooga

37660

GSK Investigational Site, Kingsport

39216

GSK Investigational Site, Jackson

43214

GSK Investigational Site, Columbus

48201

GSK Investigational Site, Detroit

48202

GSK Investigational Site, Detroit

64132

GSK Investigational Site, Kansas City

65212

GSK Investigational Site, Columbia

66205

GSK Investigational Site, Kansas City

73104

GSK Investigational Site, Oklahoma City

76104

GSK Investigational Site, Fort Worth

85284

GSK Investigational Site, Mesa

90095

GSK Investigational Site, Los Angeles

91505

GSK Investigational Site, Burbank

98109

GSK Investigational Site, Seattle

99508

GSK Investigational Site, Anchorage

03756

GSK Investigational Site, Lebanon

07631

GSK Investigational Site, Englewood

07962-1956

GSK Investigational Site, Morristown

GSK Investigational Site, Summit

02905

GSK Investigational Site, Providence

All Listed Sponsors
lead

Tesaro, Inc.

INDUSTRY

NCT03326193 - A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy | Biotech Hunter | Biotech Hunter