Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian Cancer

Sponsor
Takeda
Study ID
NCT03759587
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 Japanese participants with platinum-sensitive, relapsed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who achieved complete response (CR) or partial response (PR) in the last chemotherapy containing platinum-based anticancer agents.

Key Dates

Start date
Dec 28, 2018
Status verified
May 2024
Primary completion
Mar 17, 2019
Completion
Dec 28, 2022

Study Design

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

Arms

  • Experimental: Niraparib 300 mg
    Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle (up to 51 cycles).

Primary Outcome Measure

Number of Participants With Grade 3 or 4 Thrombocytopenia Occurring Within 30 Days After Initial Administration of Niraparib [ Time Frame: Up to 30 days after the first dose ]

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