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New pill may keep ovarian cancer at bay after chemo

NCT ID NCT02655016

Disease control Sponsor: Tesaro, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a daily pill called niraparib can help keep advanced ovarian cancer from coming back after initial chemotherapy. About 733 women with stage III or IV ovarian cancer who responded to platinum-based chemo took either niraparib or a placebo. The main goal was to see how long they lived without the cancer growing again. Results show niraparib can delay cancer progression, but ongoing monitoring and treatment are needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

733 people

The number who actually took part.

Started

Jul 2016

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

fallopian tube cancer ovarian cancer ovarian neoplasm primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ovarian neoplasms

Contacts and locations

Locations

  • GSK Investigational Site

    Tempe, Arizona, 85284, United States

  • GSK Investigational Site

    Tucson, Arizona, 85710, United States

  • GSK Investigational Site

    Tucson, Arizona, 85724, United States

  • GSK Investigational Site

    San Francisco, California, 94115, United States

  • GSK Investigational Site

    San Francisco, California, 94118, United States

  • GSK Investigational Site

    Santa Rosa, California, 95403, United States

  • GSK Investigational Site

    New Haven, Connecticut, 06510, United States

  • GSK Investigational Site

    Jacksonville, Florida, 32224, United States

  • GSK Investigational Site

    Miami, Florida, 33136, United States

  • GSK Investigational Site

    Atlanta, Georgia, 30342, United States

  • GSK Investigational Site

    Savannah, Georgia, 31404, United States

  • GSK Investigational Site

    Geneva, Illinois, 60555, United States

  • GSK Investigational Site

    Indianapolis, Indiana, 46237, United States

  • GSK Investigational Site

    Indianapolis, Indiana, 46260, United States

  • GSK Investigational Site

    Iowa City, Iowa, 52242, United States

  • GSK Investigational Site

    Covington, Louisiana, 70433, United States

  • GSK Investigational Site

    New Orleans, Louisiana, 70121, United States

  • GSK Investigational Site

    Baltimore, Maryland, 21215-5271, United States

  • GSK Investigational Site

    Rockville, Maryland, 20910, United States

  • GSK Investigational Site

    Burlington, Massachusetts, 01805, United States

  • GSK Investigational Site

    Grand Rapids, Michigan, 49503, United States

  • GSK Investigational Site

    Minneapolis, Minnesota, 55433, United States

  • GSK Investigational Site

    Springfield, Missouri, 97477, United States

  • GSK Investigational Site

    Neptune City, New Jersey, 07753, United States

  • GSK Investigational Site

    Harrison, New York, 10604, United States

  • GSK Investigational Site

    Mineola, New York, 11501, United States

  • GSK Investigational Site

    New York, New York, 10016, United States

  • GSK Investigational Site

    Rochester, New York, 14620, United States

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27599-7570, United States

  • GSK Investigational Site

    Wilmington, North Carolina, 28401, United States

  • GSK Investigational Site

    Columbus, Ohio, 43210, United States

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73104, United States

  • GSK Investigational Site

    Tulsa, Oklahoma, 74146, United States

  • GSK Investigational Site

    Portland, Oregon, 97210, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104, United States

  • GSK Investigational Site

    Willow Grove, Pennsylvania, 19090, United States

  • GSK Investigational Site

    Providence, Rhode Island, 02905, United States

  • GSK Investigational Site

    Charleston, South Carolina, 29425, United States

  • GSK Investigational Site

    Sioux Falls, South Dakota, 57105, United States

  • GSK Investigational Site

    Fort Worth, Texas, 76104, United States

  • GSK Investigational Site

    The Woodlands, Texas, 77380, United States

  • GSK Investigational Site

    Tyler, Texas, 75701, United States

  • GSK Investigational Site

    Salt Lake City, Utah, 84112, United States

  • GSK Investigational Site

    Kennewick, Washington, 99336, United States

  • GSK Investigational Site

    Seattle, Washington, 98104, United States

  • GSK Investigational Site

    Spokane, Washington, 99202, United States

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53226, United States

  • GSK Investigational Site

    Bonheiden, 2820, Belgium

  • GSK Investigational Site

    Brussels, 1000, Belgium

  • GSK Investigational Site

    Brussels, 1200, Belgium

  • GSK Investigational Site

    Ghent, 9000, Belgium

  • GSK Investigational Site

    Hasselt, 3500, Belgium

  • GSK Investigational Site

    Leuven, 3000, Belgium

  • GSK Investigational Site

    Libramont, 6800, Belgium

  • GSK Investigational Site

    Namur, 5000, Belgium

  • GSK Investigational Site

    Aalborg, 9000, Denmark

  • GSK Investigational Site

    Copenhagen, 2100, Denmark

  • GSK Investigational Site

    Herlev, 2730, Denmark

  • GSK Investigational Site

    Odense C, 5000, Denmark

  • GSK Investigational Site

    Kuopio, 70210, Finland

  • GSK Investigational Site

    Oulu, 90029, Finland

  • GSK Investigational Site

    Tampere, 33521, Finland

  • GSK Investigational Site

    Turku, 20520, Finland

  • GSK Investigational Site

    Angers, 49000, France

  • GSK Investigational Site

    Aachen, 52074, Germany

  • GSK Investigational Site

    Berlin, 13353, Germany

  • GSK Investigational Site

    Essen, 45136, Germany

  • GSK Investigational Site

    Fürth, 90766, Germany

  • GSK Investigational Site

    Göttingen, 37075, Germany

  • GSK Investigational Site

    Heidelberg, 69120, Germany

  • GSK Investigational Site

    Hildesheim, 31134, Germany

  • GSK Investigational Site

    Mannheim, 68167, Germany

  • GSK Investigational Site

    München, 81377, Germany

  • GSK Investigational Site

    Dublin, 8, Ireland

  • GSK Investigational Site

    Dunmore RoadWaterford, Ireland

  • GSK Investigational Site

    Galway, H91 YR71, Ireland

  • GSK Investigational Site

    Haifa, 38100, Israel

  • GSK Investigational Site

    Ramat Gan, 52621, Israel

  • GSK Investigational Site

    Tel Aviv, 64239, Israel

  • GSK Investigational Site

    Lecce, 73100, Italy

  • GSK Investigational Site

    Milan, 20132, Italy

  • GSK Investigational Site

    Milan, 20133, Italy

  • GSK Investigational Site

    Modena, 41100, Italy

  • GSK Investigational Site

    Naples, 80131, Italy

  • GSK Investigational Site

    Oslo, 0310, Norway

  • GSK Investigational Site

    Badalona, 08916, Spain

  • GSK Investigational Site

    Barcelona, 08003, Spain

  • GSK Investigational Site

    Barcelona, 08036, Spain

  • GSK Investigational Site

    Barcelona, 08907, Spain

  • GSK Investigational Site

    Barcelona, 8035, Spain

  • GSK Investigational Site

    Córdoba, 14004, Spain

  • GSK Investigational Site

    Donostia / San Sebastian, 20014, Spain

  • GSK Investigational Site

    Elche Alicante, 03203, Spain

  • GSK Investigational Site

    Girona, 17007, Spain

  • GSK Investigational Site

    Madrid, 28033, Spain

  • GSK Investigational Site

    Madrid, 28041, Spain

  • GSK Investigational Site

    Madrid, 28046, Spain

  • GSK Investigational Site

    Seville, 41013, Spain

  • GSK Investigational Site

    Seville, 41014, Spain

  • GSK Investigational Site

    Valencia, 46009, Spain

  • GSK Investigational Site

    Valencia, 46010, Spain

  • GSK Investigational Site

    Zaragoza, 50009, Spain

  • GSK Investigational Site

    Stockholm, SE-171 76, Sweden

  • GSK Investigational Site

    Uppsala, SE-751 85, Sweden

  • GSK Investigational Site

    Basel, 4031, Switzerland

  • GSK Investigational Site

    Bern, 3010, Switzerland

  • GSK Investigational Site

    Frauenfeld, 8501, Switzerland

  • GSK Investigational Site

    Zurich, 8091, Switzerland

  • GSK Investigational Site

    Blackburn, BB2 3HH, United Kingdom

  • GSK Investigational Site

    Edinburgh, G12 0YN, United Kingdom

  • GSK Investigational Site

    Exeter, EX2 5DW, United Kingdom

  • GSK Investigational Site

    Glasgow, G12 0YN, United Kingdom

  • GSK Investigational Site

    London, W12 0HS, United Kingdom

  • GSK Investigational Site

    Portsmouth, PO6 3LY, United Kingdom

  • GSK Investigational Site

    Sheffield, S10 2SJ, United Kingdom

  • GSK Investigational Site

    Truro, TR1 3LJ, United Kingdom

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