Study Evaluating the Efficacy of Maintenance Olaparib and Cediranib or Olaparib Alone in Ovarian Cancer Patients

Sponsor
University College, London
Study ID
NCT03278717
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Olaparib — DRUG
    Olaparib is a PARP inhibitor, targeting DNA repair processes.
  • Cediranib — DRUG
    Cediranib is an inhibitor of vascular endothelial growth factor-A (VEGF), targeting angiogenesis.

Study Details

ICON 9 will assess the efficacy, safety and tolerability of maintenance olaparib in combination with cediranib compared to maintenance olaparib alone following a response to platinum-based chemotherapy in women with relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer. Prognostic and predictive factors will be studied from tumour and blood samples.

Key Dates

Start date
Jun 15, 2018
Status verified
Jun 2022
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
330 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib and Cediranib
    Patients will receive oral olaparib 300mg BD and oral cediranib 20mg OD. Patients will attend hospital for a 2 weekly review for the first 8 weeks, then 4 weekly for year 1 and 8 weekly for year 2 onwards until discontinuation of all trial drugs. Treatment may continue beyond progression until the next line of treatment if the patient is deemed to still be deriving clinical benefit. QOL instruments will be collected at baseline, every clinic visit and continue to be completed after relapse.
  • Active Comparator: Olaparib
    Patients will receive oral olaparib 300mg BD. Patients will attend hospital for a 2 weekly review for the first 8 weeks, then 4 weekly for year 1 and 8 weekly for year 2 onwards until discontinuation of all trial drugs. Treatment may continue beyond progression until the next line of treatment if the patient is deemed to still be deriving clinical benefit. QOL instruments will be collected at baseline, every clinic visit and continue to be completed after relapse.

Primary Outcome Measure

Progression free survival (PFS) measured from the date of randomisation to the date of objective progression (investigator assessed using RECIST v1.1) or date of death from any cause (in the absence of progression) [ Time Frame: 3 years ]

Central Contacts

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