CompletedPhase 2

Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer

United States79 participantsStarted 2019-03-06

Plain-language summary

This study seeks to determine the effectiveness of Rucaparib as maintenance therapy for metastatic and recurrent endometrial cancer, after 1-2 prior lines of therapy.

Who can participate

Age range18 Years – 89 Years

SexFEMALE

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Inclusion criteria

✓. Provision to sign and date the consent form.
✓. Stated willingness to comply with all study procedures and be available for the duration of the study.
✓. Be a female aged 18-89.
✓. Patients with a primary Stage III/IV or recurrent endometrial cancer.
✓. Patients have received at least one prior chemotherapy regimen and no more than two prior cytotoxic regimens (including hormonal therapy).
✓. Primary chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles.
✓. Previous cytotoxic regimen at least 4 weeks before initiation and no more than 8 weeks from initiation after last dose of previous therapy.
✓. Patients who receive radiation to the whole pelvis or at least 50% of the spine must complete radiation therapy and have at least 4 weeks' time elapse prior to initiation of drug.

Exclusion criteria

✕. Inability to comply with study and follow-up procedures
✕. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the past 3 months, unstable arrhythmias, or unstable angina
✕. Known clinically significant liver disease defined as AST and ALT \> 3.0 x ULN and/or Total bilirubin \> or = 1.5 x ULN, or documented history of active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease
✕. Participation in investigational clinical trial within last 30 days
✕. History of significant chronic disease including HIV/AIDS or hepatitis C
✕. Inability to provide informed consent
✕. Known central nervous system (CNS) malignancy or CNS metastases
✕. Patients with previous malignancy, other than endometrial, within the past 2 years from cycle 1, day 1, with the exception of those with negligible risk of metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the breast.

What they're measuring

Progression Free Survival (PFS)

Timeframe: Up to 48 months.

Trial details

NCT IDNCT03617679

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-31

Results submitted2024-05-22

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