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A Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

NCT02655016

Description:

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.

Related Conditions:
  • Fallopian Tube Carcinoma
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
  • 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

Clinical Trial IDs

  • ORG STUDY ID: PR-30-5017-C
  • NCT ID: NCT02655016

Conditions

  • Ovarian Cancer

Interventions

DrugSynonymsArms
NiraparibNiraparib
PlaceboPlacebo

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
NiraparibExperimentalAdministered once daily continuously during a 28 day cycle.
  • Niraparib
PlaceboPlacebo ComparatorAdministered once daily continuously over a 28 day cycle
  • Placebo

Eligibility Criteria

        Main Inclusion Criteria:

          -  Patient must have histologically confirmed, advanced (FIGO Stage III or IV) high-grade
             predominantly serous or endometrioid ovarian cancer, fallopian tube cancer, or primary
             peritoneal cancer who have completed first line platinum based chemotherapy
             (neoadjuvant or adjuvant)

          -  Patient must have clinical complete response or partial response following completion
             of chemotherapy course.

          -  All Stage IV patients are eligible, irrespective of residual disease, after primary or
             interval debulking. Stage III patients are required to have visible residual disease
             after primary surgery. Patients with inoperable Stage III and IV disease are eligible

          -  Patient must agree to undergo central tumor HRD testing

          -  Patients of childbearing potential must have negative pregnancy serum test within 72
             hours of being dosed

          -  Patient must be randomized within 12 weeks of the first day of the last cycle of
             chemotherapy

        Main Exclusion Criteria:

          -  Patient has mucinous or clear cell subtypes of epithelial ovarian cancer,
             carcinosarcoma or undifferentiated ovarian cancer

          -  Patient has undergone more than 2 debulking surgeries

          -  Patient is to receive bevacizumab as maintenance treatment

          -  Patient is pregnant, breastfeeding, or expecting to conceive children, while receiving
             study treatment and for 180 days after the last dose of study treatment

          -  Patient has had prior treatment with a known PARP inhibitor

          -  Patient has been diagnosed and/or treated for any invasive cancer (other than study
             disease) less than 5 years prior to study enrollment.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:The time from treatment randomization to the earlier date of assessment of progression or death by any cause in the absence of progression.

Secondary Outcome Measures

Measure:Overall Survival
Time Frame:48 months
Safety Issue:
Description:From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
Measure: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
Safety Issue:
Description:From date of screening until the date of study discontinuation or date of death from any cause, whichever came first
Measure:Patient Reported Outcomes (PROs)
Time Frame:48 months
Safety Issue:
Description:
Measure:Time to progression on the next anticancer therapy (PFS2)
Time Frame:48 months
Safety Issue:
Description:From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Tesaro, Inc.

Trial Keywords

  • Ovarian Cancer
  • PARP Inhibitor
  • HRD
  • HRD positive
  • PRIMA
  • PRIMA Clinical Trial
  • PRIMA Study

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