A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
|ClinicalTrials.gov Identifier: NCT01847274|
Recruitment Status : Completed
First Posted : May 6, 2013
Last Update Posted : December 13, 2016
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.
The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).
|Condition or disease||Intervention/treatment||Phase|
|Platinum Sensitive Ovarian Cancer||Drug: Active comparator: Niraparib Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||597 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.|
|Study Start Date :||June 2013|
|Primary Completion Date :||June 2016|
|Study Completion Date :||June 2016|
U.S. FDA Resources
Active Comparator: Niraparib
2:1 Ratio administered once daily continuously during a 28 day cycle.
Drug: Active comparator: Niraparib
Niraparib vs placebo 2:1 ratio
Other Name: Niraparib
Placebo Comparator: Placebo
Administered once daily continuously over a 28 day cycle.
- Progression free survival of ovarian cancer patients [ Time Frame: 35 months ]The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS). In the non-gBRCAmut cohort, PFS will be hierarchically evaluated first in HRD+ patients and then in all non-gBRCAmut patients.
- Patient Reported Outcomes [ Time Frame: 35 months ]Functional Assessment of Cancer therapy - Ovarian Symptom Index (FOSI) EQ-5D-5L Neuropathy Questionnaire
- Progression Free Survival Two [ Time Frame: 35 months ]Time from treatment randomization to the earlier date of assessment of progression on the next anti-cancer therapy following study treatment or death by any cause.
- Chemotherapy Free Interval [ Time Frame: 35 Months ]Chemotherapy free interval (CFI) is the time from last platinum dose until initiation of the next anticancer therapy
- Overall Survival of Ovarian Cancer Patients [ Time Frame: 35 Months ]
- Evaluate the safety and tolerability of niraparib in ovarian cancer patients [ Time Frame: 35 months ]Review of adverse events, physical exams, electrocardiograms (ECGs), and safety lab values
- BRACA diagnostic test [ Time Frame: 35 months ]Concordance of a candidate companion diagnostic test compared to centralized BRCA mutation test
- HRD diagnostic test [ Time Frame: 35 months ]Concordance of a candidate companion HRD diagnostic test compared to centralized HRD test
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847274
Show 108 Study Locations
|Principal Investigator:||Mansoor Raza Mirza, MD||Rigshospitalet, Denmark|
|Principal Investigator:||Ursula Matulonis, MD||Dana-Farber Cancer Institute|