A Phase 2, Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Efficacy of Niraparib in Japanese Patients With Advanced, Relapsed, High-grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received 3 or 4 Previous Chemotherapy Regimens
Overview
- Phase
- Phase 2
- Intervention
- Niraparib
- Conditions
- Ovarian Cancer
- Sponsor
- Takeda
- Enrollment
- 20
- Locations
- 33
- Primary Endpoint
- Objective Response Rate (ORR)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
The drug being tested in this study is called niraparib. Niraparib is being tested to treat people who have the homologous recombination deficiency (HRD)-positive, advanced, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. This study will look at the efficacy and safety of niraparib in Japanese participants. The study will enroll approximately 16 participants. Participants will be enrolled to one group and after that will be asked to take niraparib capsules at the same time each day throughout the study: - Niraparib 300 mg This multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 23 months. Participants will make multiple visits to the clinic in the treatment period, and the post-treatment period including follow-up assessments after the last dose of the study drug.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Niraparib
Outcomes
Primary Outcomes
Objective Response Rate (ORR)
Time Frame: Until disease progression or death (Up to 3.8 years)
ORR was defined as the percentage of participants achieving CR or PR as assessed by the Investigator per RECIST v.1.1. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in SoD of target lesions, taking as a reference the Baseline SoD.
Secondary Outcomes
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years))
- Number of Participants With TEAEs Leading to Drug Discontinuation(From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years))
- Disease Control Rate (DCR)(Until disease progression or death (Up to 3.8 years))
- Number of Participants With Serious TEAEs(From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years))
- Duration of Response (DOR)(Until disease progression or death (Up to 3.8 years))
- Number of Participants With Grade 3 or Higher TEAEs(From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years))
- Number of Participants With TEAEs Leading to Dose Interruption(From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years))
- Number of Participants With TEAEs Leading to Dose Reduction(From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years))
- Progression Free Survival (PFS)(Until disease progression or death (Up to 3.8 years))
- Overall Survival (OS)(From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years))