Active — Not RecruitingPhase 3

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

United States733 participantsStarted 2016-07-11

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Exclusion criteria

✕. Participant received a transfusion (platelets or red blood cells) within 2 weeks of the first dose of study treatment.
✕. 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.

What they're measuring

Progression Free Survival

Timeframe: Up to 34 months

Trial details

NCT IDNCT02655016

SponsorTesaro, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-05-17

Results submitted2020-05-04

View on ClinicalTrials.gov More Ovarian Neoplasms trials