Olaparib in Patients With Recurrent Ovarian Cancer Wild Type for Germline and Somatic BRCA 1 and 2 Genes: The MITO 31 Translational Study

Phase 2

Recruiting

• Conditions: BRCA Wild Type Platinum Sensitive Recurrent Ovarian Cancer
• Interventions: Drug: Olaparib tablets

• Registration Number: NCT04091204
• Lead Sponsor: National Cancer Institute, Naples

Brief Summary

The aim of the study is to explore a prognostic clinical and molecular biomarker profile in a population of BRCA wild-type recurrent high-grade ovarian cancer patients treated with olaparib as maintenance after response to a platinum based therapy as platinum sensitive recurrence treatment.

Detailed Description

This is a single arm, open-label Phase 2 study designed to evaluate the effect of maintenance olaparib treatment after response to platinum-based chemotherapy in patients with BRCA wild type platinum sensitive recurrent ovarian cancer. The goal is to identify a clinical and molecular profile able to select a group of patients, treated with olaparib as maintenance, with a favorable prognosis.

Study Timeline

• Study Start: 2019-07-04
• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-16
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Olaparib	Olaparib tablets	Olaparib is given orally at the dose of 300 mg bid continually as maintenance therapy after a platinum based chemotherapy

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	up to 24 months	as determined by investigator

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival 2	up to 36 months	as determined by investigator, after the subsequent line of treatment
Overall Survival	up to 36 months	as determined by investigator
Response Rate	up to 24 months	according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Worst grade toxicity per patient	evaluated at each cycle every 28 days (during maintenance therapy), up to 30 days after cessation of olaparib	graded according to Common Terminology Criteria for Adverse Event (CTCAE) version 5.0

Trial Locations

Locations (1)

Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico; 🇮🇹 Napoli, Italy