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

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Tesaro, Inc.
Study ID
NCT03326193
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Niraparib — DRUG
    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.
  • Bevacizumab — BIOLOGICAL
    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.

Study Details

Niraparib is an oral inhibitor of poly adenosine diphosphate-ribose polymerase (PARP)-1 and PARP-2. This study will evaluate safety and efficacy of niraparib combined with bevacizumab as maintenance treatment in participants with advanced (stage IIIB-IV) ovarian cancer, fallopian tube cancer, or primary peritoneal cancer following front-line platinum-based chemotherapy with bevacizumab. Eligible participants who achieve complete response (CR), partial response (PR), or no evidence of disease (NED) following treatment with platinum-based chemotherapy in addition to bevacizumab will be enrolled in the study and will receive maintenance treatment with niraparib (for up to 3 years) combined with bevacizumab (for up to 10 months during the maintenance phase or up to a total of 15 months inclusive of the approximately 5 months of bevacizumab received with chemotherapy) or until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death, whichever comes first. Participants who have not progressed after 3 years of niraparib maintenance treatment may continue with niraparib beyond 3 years if they are benefiting from treatment, upon consultation with Sponsor.

Key Dates

Start date
Dec 12, 2017
Status verified
Jul 2025
Primary completion
Dec 24, 2020
Completion
Jul 12, 2024

Study Design

Enrollment
105 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants receiving niraparib+ bevacizumab
    Participants will be administered bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute (min) intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib will be administered orally once a day continuously throughout each 21-day cycle (84-day cycle after amendment 2). On Day 1 of each cycle, niraparib will be administered upon completion of bevacizumab infusion. The starting dose of niraparib will be based on the participant's Baseline actual body weight or platelet count.

Primary Outcome Measure

Progression Free Survival (PFS) Rate [ Time Frame: At 18 months ]

Locations (29)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteMobileAlabama36604-
GSK Investigational SiteAnchorageAlaska99508-
GSK Investigational SiteMesaArizona85284-
GSK Investigational SiteBurbankCalifornia91505-
GSK Investigational SiteLos AngelesCalifornia90095-
GSK Investigational SiteFort MyersFlorida33908-
GSK Investigational SiteSt. PetersburgFlorida33705-
GSK Investigational SiteKansas CityKansas66205-
GSK Investigational SiteDetroitMichigan48201-
GSK Investigational SiteDetroitMichigan48202-
GSK Investigational SiteJacksonMississippi39216-
GSK Investigational SiteColumbiaMissouri65212-
GSK Investigational SiteKansas CityMissouri64132-
GSK Investigational SiteLebanonNew Hampshire03756-
GSK Investigational SiteEnglewoodNew Jersey07631-
GSK Investigational SiteMorristownNew Jersey07962-1956-
GSK Investigational SiteSummitNew Jersey07962-1956-
GSK Investigational SiteAlbanyNew York12208-
GSK Investigational SiteRochesterNew York14642-
GSK Investigational SiteAshevilleNorth Carolina28816-
GSK Investigational SiteColumbusOhio43214-
GSK Investigational SiteOklahoma CityOklahoma73104-
GSK Investigational SitePittsburghPennsylvania15224-
GSK Investigational SiteProvidenceRhode Island02905-
GSK Investigational SiteChattanoogaTennessee37403-
GSK Investigational SiteKingsportTennessee37660-
GSK Investigational SiteNashvilleTennessee37203-
GSK Investigational SiteFort WorthTexas76104-
GSK Investigational SiteSeattleWashington98109-

Find similar trials in Mobile, AL

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
GSK Investigational Site· Mobile, ALGSK Investigational Site· Anchorage, AKGSK Investigational Site· Mesa, AZGSK Investigational Site· Burbank, CAGSK Investigational Site· Los Angeles, CAGSK Investigational Site· Fort Myers, FL

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