Conditions: Ovarian Neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 123
Healthy volunteers: no

Brief summary:
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

Detailed description:
Both the experimental arms (Arm B and C) will be compared with Arm A in terms of PFS.

If both superior to the control (Arm A), they will be compared in terms of gastrointestinal safety.

Arms:
arm 1: Intravenous administration of weekly Paclitaxel (dosage: 80 mg/mq) for a maximum of 6 cycles. Cycle is defined as 4 weeks. arm 2: 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. arm 3: 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.

Interventions: intervention 1: Paclitaxel intervention 2: Cediranib intervention 3: Olaparib
Intervention descriptions: intervention 1: Comparator active compound intervention 2: Experimental compound intervention 3: Experimental compound

Protocol document:
Prot_000.pdf: 



















































































































































































































































SAP_001.pdf: