Japan Phase 2 Study of Niraparib in Participants With Advanced, Relapsed Ovarian Cancer

Sponsor
Takeda
Study ID
NCT03759600
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to evaluate the safety and efficacy of niraparib in participants with advanced, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 3 or 4 previous chemotherapy regimens.

Key Dates

Start date
Dec 26, 2018
Status verified
Jul 2024
Primary completion
Dec 28, 2022
Completion
Dec 28, 2022

Study Design

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

Arms

  • Experimental: Niraparib 300 mg
    Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Until disease progression or death (Up to 3.8 years) ]

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