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

Sponsor
Mario Negri Institute for Pharmacological Research
Study ID
NCT06121401
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Carcinoma, Ovarian Epithelial

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 15, 2023
Status verified
Sep 2025
Primary completion
Mar 15, 2027
Completion
Sep 15, 2027

Study Design

Enrollment
190 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Olaparib - Bevacizumab
    Olaparib 300 mg 2\*daily + Bevacizumab 15mg/kg (q3w)

Primary Outcome Measure

Proportion of patients treated with olaparib [ Time Frame: 42 months ]

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