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First Line Treatment With Olaparib in Combination With Bevacizumab in HRD Positive Patients
Sponsor: Mario Negri Institute for Pharmacological Research
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
2026-06-25
Healthy Volunteers
No
Conditions
Interventions
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
Bevacizumab
Bevacizumab will be taken at a dose of 15 mg per kilogram of body weight every 3 weeks
Locations (14)
Azienda Socio Sanitaria Territoriale (ASST) Lariana
San Fermo della Battaglia, Como, Italy
Spedali Civili
Brescia, Italy
Policlinico Careggi
Florence, Italy
Ospedale Manzoni
Lecco, Italy
Ospedale San Luca
Lucca, Italy
Istituto Europeo di Oncologia
Milan, Italy
Istituto Nazionale dei Tumori
Milan, Italy
Istituto Oncologico Veneto IRCCS
Padova, Italy
AOU Parma
Parma, Italy
Ospedale Santa Chiara
Pisa, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
Ospedale Umberto I
Roma, Italy
A.O. Ordine Mauriziano
Torino, Italy
A.O.U. Citta della Salute e della Scienza
Torino, Italy