A Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
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|ClinicalTrials.gov Identifier: NCT02655016|
Recruitment Status : Active, not recruiting
First Posted : January 13, 2016
Last Update Posted : August 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Niraparib Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||620 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||February 2020|
Administered once daily continuously during a 28 day cycle.
Niraparib vs Placebo 2:1 ratio
Placebo Comparator: Placebo
Administered once daily continuously over a 28 day cycle
- Progression Free Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first - Approximately 15 months ]The time from treatment randomization to the earlier date of assessment of progression or death by any cause in the absence of progression.
- Overall Survival [ Time Frame: 48 months ]From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
- Safety and tolerability of Niraparib versus Placebo as Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [ Time Frame: 48 months ]From date of screening until the date of study discontinuation or date of death from any cause, whichever came first
- Patient Reported Outcomes (PROs) [ Time Frame: 48 months ]
- Time to progression on the next anticancer therapy (PFS2) [ Time Frame: 48 months ]From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first.
- AUC0-last [ Time Frame: Up to 32 weeks ]AUC Area Under the Curve, time from 0 to the last quantifiable concentration
- AUC [ Time Frame: Up to 32 weeks ]AUC Area Under the Curve, time from 0 to the last quantifiable concentration
- Peak Plasma Concentration (Cmax) [ Time Frame: Up to 32 weeks ]Cmax Observed maximum plasma concentration
- HRD Diagnostic Test [ Time Frame: Samples for BRCA and HRD diagnostic testing will be obtained at screening and tested during the study. Additional biomarkers may be tested from an optional tumor sample if available at study treatment discontinuation, approximately 48 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655016