Olaparib +/- Cediranib or Chemotherapy in Patients With Platinum-resistant Ovarian Cancer

Sponsor
University of Oxford
Study ID
NCT03117933
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Olaparib — DRUG
    Tablet, 100mg and 150mg
  • Cediranib — DRUG
    Tablet 15mg and 20mg
  • Paclitaxel — DRUG
    Intravenous (IV)

Study Details

The trial will compare the drugs olaparib and cediranib with standard chemotherapy in platinum resistant ovarian cancer. Patients will be randomised to one of three treatment groups: olaparib only, olaparib and cediranib and the control group paclitaxel. The aim is to compare efficacy of the 3 treatments and also how well each treatment is tolerated including the participants quality of life.

Key Dates

Start date
Mar 9, 2017
Status verified
Jan 2024
Primary completion
Mar 12, 2021
Completion
Dec 31, 2023

Study Design

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

Arms

  • Active Comparator: A: Paclitaxel
    Paclitaxel, IV weekly, 80mg/m2; until progression
  • Experimental: B: Olaparib
    Olaparib, oral, 300mg twice daily; until progression
  • Experimental: C: Olaparib and Cediranib
    Olaparib, oral, 300mg twice daily and Cediranib, tablet, 20mg once daily; until progression

Primary Outcome Measure

Progression free survival [ Time Frame: up to 18 months ]

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