CompletedPhase 2

Trial of Maintenance With Niraparib- Uterine Serous Carcinoma

United States22 participantsStarted 2019-12-30

Plain-language summary

Uterine serous carcinoma (USC) accounts for up to 40% of endometrial cancer-related deaths. Patients with USC share many genomic and clinical characteristics with patients who has serous ovarian cancer. The objective of this study is to evaluate the efficacy of maintenance Niraparib regimen in patients with advanced or platinum sensitive recurrent uterine serous carcinoma. Additionally, the investigators aim to further describe the safety of this regimen. The investigators hypothesize that Niraparib maintenance will be a well-tolerated treatment and show significant response in patients with uterine serous carcinoma.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Female, age at least 18 years
✓. ECOG performance status of \<2
✓. Written voluntary informed consent
✓. Histologically diagnosed Uterine Serous Carcinoma.
✓. Patient must agree to undergo Foundation One testing.
✓. Patient diagnosed with advanced stage USC including stage III, stage IV, or platinum-sensitive recurrent USC
✓. If recurrent USC, patient must have platinum sensitive disease after initial treatment; defined as achieving a response (CR or PR) and disease progression \>6 months after completion of their last dose of platinum chemotherapy.
✓. Patients eligible if receiving 1st or 2nd line chemotherapy for recurrence.

What they're measuring

PFS

Timeframe: 1 year

Trial details

NCT IDNCT04080284

SponsorNorthwell Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-01

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