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)
EU CTIS ID: 2022-502242-27-00
What this study is testing
- 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. - 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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.