A CLINICAL TRIAL TO CONFIRM THE EFFICACY OF OLAPARIB IN COMBINATION WITH BEVACIZUMAB, ADMINISTERED AS MAINTENANCE THERAPY AFTER A FRONTLINE PLATINUM BASED CHEMOTHERAPY PLUS BEVACIZUMAB, IN THE TREATMENT OF PATIENTS WITH OVARIAN TUMOURS SHOWING A GENETIC DEFECTS IN A DNA REPAIR MECHANISM CALLED HOMOLOGOUS RECOMBINATION (DEFINED AS HRD POSITIVE, WHERE HRD MEANS HOMOLOGOUS RECOMBINATION DEFICIENCY)

Phase 1

Recruiting

• Registration Number: CTIS2022-502242-27-00
• Lead Sponsor: Mario Negri Institute For Pharmacological Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-02
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 190

Inclusion Criteria

1.Provision of informed consent. 2.Subject must be = 18 years of age inclusive, at the time of signing the informed consent form. 3.Patient with newly diagnosed high-grade epithelial ovarian, primary peritoneal and/or fallopian-tube cancer 4.Patients with advanced disease (FIGO stage III-IV). 5.Formalin-fixed, paraffin-embedded (FFPE) tumour samples from primary cancer must be available for the central testing of HRD status (Myriad Mychoice CDx Plus). If there is not written confirmation of the availability of an archived tumour sample before enrolment, the patient will not be eligible for the study. 6.Patients suitable to receive a platinum-taxane chemotherapy plus bevacizumab. 7.Patients must have normal organ and bone marrow function values measured before administration of platinum-based chemotherapy plus bevacizumab 8.Normal blood pressure (BP) or adequately treated and controlled hypertension (systolic BP = 140 mmHg and/or diastolic BP = 90 mmHg 9.Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 10.Patients must have a life expectancy = 16 weeks.

Exclusion Criteria

1.Any previous treatment with PARP inhibitor, including Olaparib. 2.Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML. 3.Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. 4.Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent. 5.Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication. 6.Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV). 7.Patients with known active hepatitis (i.e. Hepatitis B or C). 8.Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT). 9.Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures (including sample collection), restrictions and requirements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified