A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer

Official Title

A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.

Summary:

This is a Phase 3, multicentre, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumour 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).

Trial Description

Primary Outcome:

  • Progression-Free Survival (PFS) in Cohort With Germline BRCA Mutation (gBRCA)
  • Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumours (Non-gBRCAmut HRD+)
  • Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation (Non-gBRCA)
Secondary Outcome:
  • Time to First Subsequent Therapy (TFST) in Cohort With Germline BRCA Mutation (gBRCA)
  • Time to First Subsequent Therapy (TFST) in Cohort With No Germline BRCA Mutation (Non-gBRCA)
  • Chemotherapy-Free Interval (CFI) in Cohort With Germline BRCA Mutation (gBRCA)
  • Chemotherapy-Free Interval (CFI) in Cohort With No Germline BRCA Mutation (Non-gBRCA)
  • Progression-Free Survival 2 (PFS2) in Cohort With Germline BRCA Mutation (gBRCA)
  • Progression-Free Survival 2 (PFS2) in Cohort With No Germline BRCA Mutation (Non-gBRCA)
  • Overall Survival (OS) in Cohort With Germline BRCA Mutation (gBRCA)
  • Overall Survival (OS) in Cohort With No Germline BRCA Mutation (Non-gBRCA)
  • Time to Second Subsequent Therapy (TSST) in Cohort With Germline BRCA Mutation (gBRCA)
  • Time to Second Subsequent Therapy (TSST) in Cohort With No Germline BRCA Mutation (Non-gBRCA)
  • Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With Germline BRCA
  • Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With Germline BRCA
  • Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With Germline BRCA
  • Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With Germline BRCA
  • Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With no Germline BRCA
  • Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With no Germline BRCA
  • Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With no Germline BRCA
  • Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With no Germline BRCA
  • Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA
  • Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA
  • Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA
  • Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA
  • Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA
  • Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA
  • Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA
  • Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society