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ACTIVE NOT RECRUITING
NCT06121401
PHASE4

First Line Treatment With Olaparib in Combination With Bevacizumab in HRD Positive Patients

Sponsor: Mario Negri Institute for Pharmacological Research

View on ClinicalTrials.gov

Summary

The goal of this prospective, phase IV, multi-centre clinical trial is to to define the proportion of patients with advanced high grade epithelial ovarian cancer (EOC) HRD-positive who will be treated at first line with olaparib in combination with bevacizumab as maintenance and to describe their clinical and demographic characteristics. Other primary objective is to confirm, in a setting close to clinical practice, the efficacy of olaparib concomitant with bevacizumab as maintenance treatment after first-line chemotherapy in patients with advanced high grade EOC HRD-positive and who have received bevacizumab in combination with chemotherapy.

Official title: A Phase IV Trial to Confirm the Efficacy of Olaparib in Combination With Bevacizumab as Frontline Treatment of HRD Positive Ovarian Tumors

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

190

Start Date

2023-09-15

Completion Date

2027-09-15

Last Updated

2025-09-17

Healthy Volunteers

No

Interventions

DRUG

Olaparib

Olaparib is considered the study treatment. Olaparib tablets will be taken at the dose of 300 mg (2 x 150 mg tablet) twice daily adding to bevacizumab at a dose of 15 mg per kilogram of body weight every 3 weeks

DRUG

Bevacizumab

Bevacizumab will be taken at a dose of 15 mg per kilogram of body weight every 3 weeks

Locations (2)

Azienda Socio Sanitaria Territoriale (ASST) Lariana

San Fermo della Battaglia, Como, Italy

Istituto Oncologico Veneto IRCCS

Padova, Italy, Italy