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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02655016
Recruitment Status : Active, not recruiting
First Posted : January 13, 2016
Last Update Posted : August 1, 2018
Gynecologic Oncology Group
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Myriad Genetics, Inc.
Information provided by (Responsible Party):
Tesaro, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Niraparib Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 620 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
Study Start Date : April 2016
Estimated Primary Completion Date : February 2020

Arm Intervention/treatment
Experimental: Niraparib
Administered once daily continuously during a 28 day cycle.
Drug: Niraparib
Niraparib vs Placebo 2:1 ratio

Placebo Comparator: Placebo
Administered once daily continuously over a 28 day cycle
Drug: Placebo

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Patient Reported Outcomes (PROs) [ Time Frame: 48 months ]
  4. 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.

Other Outcome Measures:
  1. AUC0-last [ Time Frame: Up to 32 weeks ]
    AUC Area Under the Curve, time from 0 to the last quantifiable concentration

  2. AUC [ Time Frame: Up to 32 weeks ]
    AUC Area Under the Curve, time from 0 to the last quantifiable concentration

  3. Peak Plasma Concentration (Cmax) [ Time Frame: Up to 32 weeks ]
    Cmax Observed maximum plasma concentration

  4. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02655016

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Sponsors and Collaborators
Tesaro, Inc.
Gynecologic Oncology Group
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Myriad Genetics, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Tesaro, Inc. Identifier: NCT02655016     History of Changes
Other Study ID Numbers: PR-30-5017-C
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Keywords provided by Tesaro, Inc.:
Ovarian Cancer
PARP Inhibitor
HRD positive
PRIMA Clinical Trial
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents