Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Immune System Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Carcinoma

Disease Attributes

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Olaparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

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

Olaparib tablets

Sandro Pignata, MD, PhD

Clorinda Schettino, MD

Francesco Perrone, MD, PhD

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.

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.

This is a single arm, multicentre, open-label Phase 2 study

Female patients with histologically diagnosed relapsed high grade ovarian cancer (including primary peritoneal and /or fallopian tube cancer)

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

as determined by investigator, after the subsequent line of treatment

graded according to Common Terminology Criteria for Adverse Event (CTCAE) version 5.0

according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

National Cancer Institute, Naples

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Olaparib in Patients With Recurrent Ovarian Cancer Wild Type for Germline and Somatic BRCA 1 and 2 Genes: The MITO 31 Translational Study	NCT04091204	BRCA Wild Type ...	Olaparib tablet...	18 Years -	National Cancer Institute, Naples
Olaparib in Patients With Recurrent Ovarian Cancer Wild Type for Germline and Somatic BRCA 1 and 2 Genes: The MITO 31 Translational Study	NCT04091204	BRCA Wild Type ...	Olaparib tablet...	18 Years -	National Cancer Institute, Naples
Olaparib in Patients With Recurrent Ovarian Cancer Wild Type for Germline and Somatic BRCA 1 and 2 Genes: The MITO 31 Translational Study	NCT04091204	BRCA Wild Type ...	Olaparib tablet...	18 Years -	National Cancer Institute, Naples

Spots Global Cancer Trial Database for brca wild type platinum sensitive recurrent ovarian cancer