Study on Niraparib Maintenance Treatment for Advanced Ovarian Cancer After Initial Chemotherapy Response
Sponsor: Tesaro, Inc.
ClinicalTrials ID:NCT02655016
This clinical trial is evaluating the effectiveness of Niraparib as a maintenance treatment for patients with advanced ovarian cancer who have responded to initial platinum-based chemotherapy. The study will last approximately 7 years.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to determine if Niraparib can help maintain the positive effects of initial chemotherapy in patients with advanced ovarian cancer (Stage III or IV). Participants must have completed their first round of platinum-based chemotherapy with either a complete or partial response to be eligible. The study will collect data over a period of about 7 years to assess the long-term benefits of Niraparib as a maintenance therapy.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with high-grade serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer at Stage III or IV.
- Have inoperable Stage III or IV cancer, or have had surgery and chemotherapy for Stage III or IV cancer.
- Completed 6 to 9 cycles of platinum-based chemotherapy, with at least 2 cycles after surgery.
- Achieved a complete or partial response to chemotherapy, with stable cancer marker levels.
- Must start the study within 12 weeks after the last chemotherapy cycle.
- Agree to undergo specific tumor testing.
- Women of childbearing potential must have a negative pregnancy test before starting the study.
Exclusion Criteria
- Have certain types of ovarian cancer, such as mucinous or clear cell subtypes.
- Have had complete removal of cancer with no visible disease after surgery.
- Have had more than two surgeries for the cancer.
- Are pregnant, breastfeeding, or planning to become pregnant during the study and for 180 days after.
- Have allergies to Niraparib or its ingredients.
- Have previously used PARP inhibitors or are receiving another maintenance treatment.
- Have received experimental treatments recently.
- Have severe blood cell issues from previous chemotherapy that lasted more than 4 weeks.
- Have conditions or treatments that could interfere with the study, such as recent blood transfusions or use of certain growth factors.
- Have had another invasive cancer diagnosed or treated within the last 5 years.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| GSK Investigational Site | 85284 | Tempe | Arizona |
| GSK Investigational Site | 85710 | Tucson | Arizona |
| GSK Investigational Site | 85724 | Tucson | Arizona |
| GSK Investigational Site | 94115 | San Francisco | California |
| GSK Investigational Site | 94118 | San Francisco | California |
| GSK Investigational Site | 95403 | Santa Rosa | California |
| GSK Investigational Site | 06510 | New Haven | Connecticut |
| GSK Investigational Site | 32224 | Jacksonville | Florida |
| GSK Investigational Site | 33136 | Miami | Florida |
| GSK Investigational Site | 30342 | Atlanta | Georgia |
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