Best Approach in Recurrent-Ovarian-Cancer-with Cediranib-Olaparib

Sponsor
Mario Negri Institute for Pharmacological Research
Study ID
NCT03314740
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Paclitaxel — DRUG
    Comparator active compound
  • Cediranib — DRUG
    Experimental compound
  • Olaparib — DRUG
    Experimental compound

Study Details

This is a Phase II, randomized, multi-centre study aiming at comparing the efficacy of Olaparib and Cediranib vs. weekly Paclitaxel in terms of progression free survival (PFS) in platinum refractory or resistant recurrent ovarian cancer. Patients will be randomised in a 1:1:1 ratio to three treatment arms: * Arm A: Paclitaxel 80 mg/mq every week * Arm B: Cediranib 20 mg/day + Olaparib 600 mg / day (i.e. 300 mg BD) given every day * Arm C: Cediranib 20 mg/day given 5 days per weeks + Olaparib 600 mg / day (i.e. 300 mg BD) given 7 days per weeks

Key Dates

Start date
Jun 12, 2017
Status verified
Nov 2024
Primary completion
Apr 1, 2021
Completion
Apr 1, 2021

Study Design

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

Arms

  • Active Comparator: Arm A
    Intravenous administration of weekly Paclitaxel (dosage: 80 mg/mq) for a maximum of 6 cycles. Cycle is defined as 4 weeks.
  • Experimental: Arm B
    Oral administration of two experimental drugs: * Cediranib 20 mg/day given 7 days per week * Olaparib 600 mg / day (i.e. 300 mg twice a day) 7 days per week until progression, unacceptable toxicity, patient or physician decision to discontinue or death.
  • Experimental: Arm C
    Oral administration of two experimental drugs: * Cediranib 20 mg/day given 5 days per week * Olaparib 600 mg / day (i.e. 300 mg twice a day) 7 days per week until progression, unacceptable toxicity, patient or physician decision to discontinue or death.

Primary Outcome Measure

Efficacy: Progression Free Survival (PFS) [ Time Frame: An average of 30 months for each participant ]

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