A Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
A Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
This study is a double-blind, randomized, placebo-controlled (2:1 niraparib:placebo) study in patients with Stage III or IV ovarian cancer. Patients must have completed front-line platinum based regimen with a physician-assessed response of Complete Response (CR) or Partial Response (PR). Additionally, patients must have a normal or >90% decrease in cancer antigen 125 (CA-125) following front-line platinum treatment. The study will assess the efficacy of niraparib as maintenance treatment, as measured by PFS.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 733 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date: July 7, 2016
Actual Primary Completion Date: May 17, 2019
Estimated Study Completion Date: March 29, 2024
Arm:
- Experimental: Niraparib
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 733 |
| Actual Study start date | 07 July 2016 |
| Estimated Study Completion Date | 29 March 2024 |