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ACTIVE NOT RECRUITING

NCT02655016

PHASE3

A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Sponsor: Tesaro, Inc.

View on ClinicalTrials.gov

Summary

This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in participants with Stage III or IV ovarian cancer. Participants must have completed front-line platinum based regimen with complete response (CR) or partial response (PR). Data collection for Secondary Outcome measures is ongoing and the approximate duration of the study will be 7 years.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

733

Start Date

2016-07-11

Completion Date

2026-05-29

Last Updated

2026-03-10

Healthy Volunteers

Conditions

Ovarian Neoplasms

Interventions

DRUG

Niraparib

Niraparib will be administered.

DRUG

Placebo

Placebo will be administered.

Inclusion criteria: * Participants must have histologically diagnosed high-grade serous or endometrioid, or high-grade predominantly serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is Stage III or IV according to Federation Internationale de Gynécologie et d'Obstétrique (FIGO) criteria. * Participants with inoperable Stage III and IV disease; All Stage IV participants with operable disease; Participants with stage III or IV disease treated with neoadjuvant chemotherapy and interval debulking surgery; and Participants with stage III disease who have visible residual disease after primary debulking surgery. * Participants who have received intraperitoneal chemotherapy; All participants must have had more than or equal to (\>=)6 and less than or equal to (\<=)9 cycles of platinum-based therapy; Participants must have had \>=2 post-operative cycles of platinum-based therapy following interval debulking surgery; Participants must have physician assessed Complete response (CR) or Partial response (PR) after \>=3 cycles of therapy; and Participants must have either Cancer antigen 125 (CA-125) in the normal range or CA-125 decrease by more than 90 percent(%) during their front-line therapy that is stable for at least 7 days (no increase more than (\>)15% from nadir). * Participants must be randomized within 12 weeks of the first day of the last cycle of chemotherapy. * All participants must agree to undergo central tumor HRD testing. * Participants of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin \[hCG\]) within 7 days prior to receiving the first dose of study treatment. Exclusion criteria: * Participant has mucinous or clear cell subtypes of epithelial ovarian cancer, carcinosarcoma or undifferentiated ovarian cancer. * Participants with Stage III disease who have had complete cytoreduction (no visible residual disease) after primary debulking surgery. * Participant has undergone more than two debulking surgeries for the study disease. * Participant is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for up to 180 days after the last dose of study treatment. * Participant has a known hypersensitivity to the components of niraparib or its excipients. * Participant has received prior treatment with a known PARP inhibitor or has participated in a study where any treatment arm included administration of a known PARP inhibitor. * Participant is to receive bevacizumab as maintenance treatment. * Participant has had investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study. * Participant has had any known \>=Grade 3 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted \>4 weeks. * Participant has a condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results or interfere with the participation for the full duration of the study treatment, including: 1. Participant received a transfusion (platelets or red blood cells) within 2 weeks of the first dose of study treatment. 2. Participant received colony-stimulating factors (e.g., granulocyte colony stimulating factor \[G-CSF\], granulocyte macrophage colony-stimulating factor \[GM-CSF\] or recombinant erythropoietin) within 2 weeks prior to the first dose of study treatment. * Participant has been diagnosed and/or treated for invasive cancer less than 5 years prior to study enrollment.

Locations (116)

GSK Investigational Site

Tempe, Arizona, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

Santa Rosa, California, United States

GSK Investigational Site

New Haven, Connecticut, United States

GSK Investigational Site

Jacksonville, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Savannah, Georgia, United States

GSK Investigational Site

Geneva, Illinois, United States

GSK Investigational Site

Indianapolis, Indiana, United States

GSK Investigational Site

Indianapolis, Indiana, United States

GSK Investigational Site

Iowa City, Iowa, United States

GSK Investigational Site

Covington, Louisiana, United States

GSK Investigational Site

New Orleans, Louisiana, United States

GSK Investigational Site

Baltimore, Maryland, United States

GSK Investigational Site

Rockville, Maryland, United States

GSK Investigational Site

Burlington, Massachusetts, United States

GSK Investigational Site

Grand Rapids, Michigan, United States

GSK Investigational Site

Minneapolis, Minnesota, United States

GSK Investigational Site

Springfield, Missouri, United States

GSK Investigational Site

Neptune City, New Jersey, United States

GSK Investigational Site

Harrison, New York, United States

GSK Investigational Site

Mineola, New York, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Rochester, New York, United States

GSK Investigational Site

Chapel Hill, North Carolina, United States

GSK Investigational Site

Wilmington, North Carolina, United States

GSK Investigational Site

Columbus, Ohio, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Tulsa, Oklahoma, United States

GSK Investigational Site

Portland, Oregon, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Willow Grove, Pennsylvania, United States

GSK Investigational Site

Providence, Rhode Island, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Sioux Falls, South Dakota, United States

GSK Investigational Site

Fort Worth, Texas, United States

GSK Investigational Site

The Woodlands, Texas, United States

GSK Investigational Site

Tyler, Texas, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

Kennewick, Washington, United States

GSK Investigational Site

Seattle, Washington, United States

GSK Investigational Site

Spokane, Washington, United States

GSK Investigational Site

Milwaukee, Wisconsin, United States

GSK Investigational Site

Bonheiden, Belgium

GSK Investigational Site

Brussels, Belgium

GSK Investigational Site

Brussels, Belgium

GSK Investigational Site

Ghent, Belgium

GSK Investigational Site

Hasselt, Belgium

GSK Investigational Site

Leuven, Belgium

GSK Investigational Site

Libramont, Belgium

GSK Investigational Site

Namur, Belgium

GSK Investigational Site

Aalborg, Denmark

GSK Investigational Site

Copenhagen, Denmark

GSK Investigational Site

Herlev, Denmark

GSK Investigational Site

Odense C, Denmark

GSK Investigational Site

Kuopio, Finland

GSK Investigational Site

Oulu, Finland

GSK Investigational Site

Tampere, Finland

GSK Investigational Site

Turku, Finland

GSK Investigational Site

Angers, France

GSK Investigational Site

Aachen, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Essen, Germany

GSK Investigational Site

Fürth, Germany

GSK Investigational Site

Göttingen, Germany

GSK Investigational Site

Heidelberg, Germany

GSK Investigational Site

Hildesheim, Germany

GSK Investigational Site

Mannheim, Germany

GSK Investigational Site

München, Germany

GSK Investigational Site

Dublin, Ireland

GSK Investigational Site

Dunmore RoadWaterford, Ireland

GSK Investigational Site

Galway, Ireland

GSK Investigational Site

Haifa, Israel

GSK Investigational Site

Ramat Gan, Israel

GSK Investigational Site

Tel Aviv, Israel

GSK Investigational Site

Lecce, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Modena, Italy

GSK Investigational Site

Naples, Italy

GSK Investigational Site

Oslo, Norway

GSK Investigational Site

Badalona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Córdoba, Spain

GSK Investigational Site

Donostia / San Sebastian, Spain

GSK Investigational Site

Elche Alicante, Spain

GSK Investigational Site

Girona, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Seville, Spain

GSK Investigational Site

Seville, Spain

GSK Investigational Site

Valencia, Spain

GSK Investigational Site

Valencia, Spain

GSK Investigational Site

Zaragoza, Spain

GSK Investigational Site

Stockholm, Sweden

GSK Investigational Site

Uppsala, Sweden

GSK Investigational Site

Basel, Switzerland

GSK Investigational Site

Bern, Switzerland

GSK Investigational Site

Frauenfeld, Switzerland

GSK Investigational Site

Zurich, Switzerland

GSK Investigational Site

Blackburn, United Kingdom

GSK Investigational Site

Edinburgh, United Kingdom

GSK Investigational Site

Exeter, United Kingdom

GSK Investigational Site

Glasgow, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

Portsmouth, United Kingdom

GSK Investigational Site

Sheffield, United Kingdom

GSK Investigational Site

Truro, United Kingdom

Clinical Research Directory

A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (116)