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

NCT06121401 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2025-09-17

No results posted yet for this study

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.

Conditions

  • Carcinoma, Ovarian Epithelial

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Principal Investigators

  • Federica Tomao · Università degli Studi di Roma "La Sapienza", Viale del Policlinico 155, Roma

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-15
Primary Completion
2027-03-15
Completion
2027-09-15

Countries

  • Italy

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06121401 on ClinicalTrials.gov