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

NCT03314740 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2025-01-10

Study results available
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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

Conditions

  • Ovarian Neoplasms

Interventions

DRUG

Paclitaxel

Comparator active compound

DRUG

Cediranib

Experimental compound

DRUG

Olaparib

Experimental compound

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Principal Investigators

  • Roldano Fossati, MD · Mario Negri Institute for Pharmacological Research

  • Nicoletta Colombo, MD · European Institute of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2021-04-01
Completion
2021-04-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03314740 on ClinicalTrials.gov