drugset / Trial / NCT04487587
A Phase II Clinical Trial of Cediranib and Olaparib Maintenance in Advanced Recurrent Cervical Cancer
Phase 2
Active not recruiting
79 enrolled
The Clatterbridge Cancer Centre NHS Foundation Trust
University of Liverpool · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
COMICE is a randomised, double blind placebo controlled Phase II trial. The trial is recruiting 108 patients with advanced recurrent cervical cancer who have completed their 1st line chemotherapy for advanced/recurrent disease. Patients will be randomised to either placebo Cediranib and Olaparib or active Cediranib and Olaparib and will remain on treatment until progression of disease, unacceptable toxicity or withdrawal of consent. Patients will be assessed for disease progression every 8 weeks through CT/MRI imaging. The primary end point is Progression Free Survival.
Timeline
- Start
- 2018-10-09
- Primary completion
- 2025-03-01
- Completion
- 2026-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cediranib | Small molecule | 20 mg | — |
| Comparator | Olaparib | Small molecule | 300 mg | — |