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Rucaparib vs. Placebo Maintenance Therapy in Endometrial Cancer
NCT03617679Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2019
- Primary completion
- Oct 2023
- Countries
- 1
- Sponsor
- University of Colorado Denver
- Modality
- Small Molecules
- Drugs
- rucaparib
- Conditions
- endometrial cancer (EC)
01
Overview
Phase 2, randomised, double-blind trial of rucaparib in endometrial cancer (EC) (2 arms), sponsored by University of Colorado Denver. Primary endpoint: Progression Free Survival at 48 months. Started Mar 2019; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Active Ingredient
Rucaparib 600mg twice daily by mouth
Placebo
Placebo tablet twice daily by mouth
03
Who it enrols
Female patients aged 18-89 with Stage III/IV or recurrent endometrial cancer who have completed 1-2 prior lines of chemotherapy without progression, with adequate organ function and ECOG 0-2.
04
Endpoints
Primary
Progression Free Survival
Secondary
Overall Survival
Incidence of Treatment-Emergent Adverse Events
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