A Phase II Clinical Trial of Cediranib and Olaparib Maintenance in Advanced Recurrent Cervical Cancer
NCT04487587 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79
Last updated 2025-02-26
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.
Conditions
Interventions
- DRUG
-
Cediranib, Olaparib
Cediranib film coated tablet, Olaparib film coated tablet
Sponsors & Collaborators
-
University of Liverpool
collaborator OTHER -
The Clatterbridge Cancer Centre NHS Foundation Trust
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-09
- Primary Completion
- 2025-03-01
- Completion
- 2026-03-01
Countries
- United Kingdom
Study Locations
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