A Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
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| ClinicalTrials.gov Identifier: NCT02655016 |
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Recruitment Status :
Active, not recruiting
First Posted : January 13, 2016
Last Update Posted : August 1, 2018
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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.
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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 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Ovarian cancer
MedlinePlus related topics:
Ovarian Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Niraparib
Administered once daily continuously during a 28 day cycle.
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Drug: Niraparib
Niraparib vs Placebo 2:1 ratio |
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Placebo Comparator: Placebo
Administered once daily continuously over a 28 day cycle
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Drug: Placebo |
Primary Outcome Measures :
- 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 :
- 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.
- 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
- Patient Reported Outcomes (PROs) [ Time Frame: 48 months ]
- 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:
- AUC0-last [ Time Frame: Up to 32 weeks ]AUC Area Under the Curve, time from 0 to the last quantifiable concentration
- AUC [ Time Frame: Up to 32 weeks ]AUC Area Under the Curve, time from 0 to the last quantifiable concentration
- Peak Plasma Concentration (Cmax) [ Time Frame: Up to 32 weeks ]Cmax Observed maximum plasma concentration
- 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 ]
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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.
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 ClinicalTrials.gov identifier (NCT number): NCT02655016
Locations
Show 195 study locations
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 ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Tesaro, Inc. |
| ClinicalTrials.gov Identifier: | NCT02655016 |
| 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.:
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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 |