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

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

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

NCT04091204•National Cancer Institute, Naples

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Patients must be ≥ 18 years of age
•2. Female patients with histologically diagnosed relapsed high grade ovarian cancer (including primary peritoneal and /or fallopian tube cancer)
•3. Documented absence of somatic and germline mutations of BRCA1 or BRCA2 genes, that is predicted to be deleterious or suspected deleterious
•4. ECOG Performance Status of 0-2
•5. Patients must have a life expectancy of at least 16 weeks
•6. Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements
•7. Availability of tumor and blood samples for molecular analyses
•8. Patients who have received at least 2 previous line of platinum containing therapy prior to randomization
•* For the penultimate chemotherapy course prior to enrolment on the study:
•* Patient defined as platinum sensitive after this treatment, defined as having disease progression greater than 6 months after completion of their last dose of platinum chemotherapy
+9 more criteria

Exclusion Criteria

•1. History or evidence of synchronous primary endometrial carcinoma, unless all of the following criteria related to the endometrial carcinoma are met:
•* stage ≤ IA
•* no more than superficial myometrial invasion
•* no lymph vascular invasion
•* not poorly differentiated (grade 3 or papillary serous or clear cell carcinoma)
•2. Other malignancy within the last 5 years, except for adequately treated non melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinomna in situ (DCIS), stage 1, grade 1 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for \> 5years
•3. Resting ECG with QTc \> 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome
•4. Participation in another clinical study with an investigational product during the chemotherapy course immediately prior to randomization
•5. Patients receiving any systemic radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
•6. Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks
+17 more criteria

Locations (1)

Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico

Naples, Italy

Key Dates

Start Date

July 4, 2019

Primary Completion Date

September 1, 2023

Completion Date

September 1, 2023

Last Updated

March 24, 2023

Enrollment

200

ESTIMATED participants

Conditions

BRCA Wild Type Platinum Sensitive Recurrent Ovarian Cancer

Interventions

Olaparib tablets

DRUG

Contacts

Sandro Pignata, MD, PhD

CONTACT

+39 081 590 3637 s.pignata@istitutotumori.na.it

Clorinda Schettino, MD

CONTACT

+39 081 590 1791 c.schettino@istitutotumori.na.it