A Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer (COHORT-C)

Part of paid clinical trials in San Francisco, California.

Sponsor
Tesaro, Inc.
Study ID
NCT06964165
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Niraparib — DRUG
    Niraparib will be administered
  • Carboplatin — DRUG
    Carboplatin will be administered
  • Paclitaxel — DRUG
    Paclitaxel will be administered

Study Details

The goal of the study is to learn whether Niraparib or Platinum-Taxane Doublet chemotherapy is better in treating participants with Homologous Recombination Deficient (HRd) Stage III/IV Ovarian Cancer (OC). This study is a sub-study of the Master protocol -OPAL (NCT03574779)

Key Dates

Start date
Apr 14, 2022
Status verified
Nov 2025
Primary completion
Jun 28, 2024
Completion
Mar 31, 2025

Study Design

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

Arms

  • Experimental: Cohort C (Niraparib)
  • Experimental: Cohort C (Carboplatin + Paclitaxel)

Primary Outcome Measure

Pre-Interval Debulking Surgery (IDS) Unconfirmed Overall Response Rate (ORR) [ Time Frame: Up to approximately 102 weeks ]

Locations (11)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteSan FranciscoCalifornia94115-
GSK Investigational SiteMiamiFlorida33136-
GSK Investigational SiteTampaFlorida33606-
GSK Investigational SiteScarboroughMaine04074-
GSK Investigational SiteBostonMassachusetts02114-
GSK Investigational SiteSt LouisMissouri63141-
GSK Investigational SiteNew YorkNew York10029-
GSK Investigational SiteNew YorkNew York77030-
GSK Investigational SiteRochesterNew York14642-
GSK Investigational SiteSioux FallsSouth Dakota57105-
GSK Investigational SiteSeattleWashington98104-

Find similar trials in San Francisco, CA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
GSK Investigational Site· San Francisco, CAGSK Investigational Site· Miami, FLGSK Investigational Site· Tampa, FLGSK Investigational Site· Scarborough, MEGSK Investigational Site· Boston, MAGSK Investigational Site· St Louis, MO

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