A Phase II Clinical Trial of Cediranib and Olaparib Maintenance in Advanced Recurrent Cervical Cancer

Sponsor
The Clatterbridge Cancer Centre NHS Foundation Trust
Study ID
NCT04487587
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 9, 2018
Status verified
Feb 2025
Primary completion
Mar 1, 2025
Completion
Mar 1, 2026

Study Design

Enrollment
79 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active
    Cediranib 20mg tablet OD (5 days out of 7) and Olaparib 300mg tablet BD (continuous) + standard of care
  • Placebo Comparator: Placebo
    Placebo Cediranib 20mg tablet OD (5 days out of 7) and Placebo Olaparib 300mg tablet BD (continuous) + standard of care

Primary Outcome Measure

Progression Free Survival [ Time Frame: The study ends when the last patient recruited has completed a minimum of 7 months on study. Recruitment period is 14 months so the maximum time a patient will be on study for is 21 months ]

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