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

Sponsor
National Cancer Institute, Naples
Study ID
NCT04091204
Phase
PHASE2
Status
Unknown

Conditions

  • BRCA Wild Type Platinum Sensitive Recurrent Ovarian Cancer

Eligibility Criteria

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

Interventions

  • Olaparib tablets — DRUG
    Olaparib is given orally at the dose of 300 mg bid continually as maintenance therapy after a platinum based chemotherapy

Study Details

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.

Key Dates

Start date
Jul 4, 2019
Status verified
Mar 2023
Primary completion
Sep 1, 2023
Completion
Sep 1, 2023

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib
    Olaparib is given orally at the dose of 300 mg bid continually as maintenance therapy after a platinum based chemotherapy

Primary Outcome Measure

Progression Free Survival [ Time Frame: up to 24 months ]

Central Contacts