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

• Sponsor: Tesaro, Inc.
• Collaborators: Gynecologic Oncology Group; European Network of Gynaecological Oncological Trial Groups (ENGOT); Myriad Genetics, Inc.
• Information provided by (Responsible Party): Tesaro, Inc.

Study Description

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

Study Design

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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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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

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.

Contacts and Locations

  Show 195 Study Locations

Sponsors and Collaborators

Tesaro, Inc.

Gynecologic Oncology Group

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Myriad Genetics, Inc.

More Information

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Responsible Party:	Tesaro, Inc.
ClinicalTrials.gov Identifier:	NCT02655016 History of Changes
Other Study ID Numbers:	PR-30-5017-C
First Posted:	January 13, 2016
Last Update Posted:	August 1, 2018
Last Verified:	July 2018

Keywords provided by Tesaro, Inc.:

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

Additional relevant MeSH terms:

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Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Urogenital Neoplasms	Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Niraparib; Poly(ADP-ribose) Polymerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents