CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 123 enrolled
Drug / intervention
Paclitaxel +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03314740
NCT03314740Phase 2Completed

Italian Multicenter Randomized Phase II Study of Weekly Paclitaxel vs. Cediranib-Olaparib (Continuous vs. Intermittent) in Patients With Platinum Resistant High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Mario Negri Institute for Pharmacological Research·interventional·Posted Oct 19, 2017·Updated Jan 10, 2025

In Brief

A Phase 2 clinical trial evaluating Paclitaxel, Cediranib, and 1 other intervention for Ovarian Neoplasms. Completed, enrolled 123 participants across 6 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
CollaboratorsAstraZeneca

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedOct 19, 2017
Enrollment StartJun 12, 2017
Primary CompletionApr 1, 2021
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 8.7 years ago

Interventions

Paclitaxeldrug

Comparator active compound

Cediranibdrug

Experimental compound

Olaparibdrug

Experimental compound