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)
Key facts
- Where
- Brescia, Como, Florence, Lecco, Milan, Padova, Reggio Emilia, Rome és Turin, OlaszországSee the 11 sites
- Phase
- 4. fázis
Where in Olaszország
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, OlaszországNo longer taking part
- Azienda Socio Sanitaria Territoriale LarianaComo, OlaszországNo longer taking part
- Careggi University HospitalFlorence, OlaszországNo longer taking part
- Alessandro Manzoni HospitalLecco, OlaszországNo longer taking part
- European Institute Of Oncology S.r.l.Milan, OlaszországNo longer taking part
- National Cancer InstituteMilan, OlaszországNo longer taking part
- Istituto Oncologico VenetoPadova, OlaszországNo longer taking part
- Azienda USL IRCCS di Reggio EmiliaReggio Emilia, OlaszországNo longer taking part
- Sapienza University Of RomeRome, OlaszországNo longer taking part
- Azienda Ospedaliera Ordine Mauriziano di TorinoTurin, OlaszországNo longer taking part
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mario Negri Institute For Pharmacological Research
- Trial code
- EU 2022-502242-27-00
- Record updated
- 2026. szeptember 4.
- Original description
- 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.Read full original descriptionShow less
A PHASE IV TRIAL TO CONFIRM THE EFFICACY OF OLAPARIB IN COMBINATION WITH BEVACIZUMAB AS MAINTENANCE FRONTLINE TREATMENT OF HRD POSITIVE OVARIAN TUMOURS (IOLANTHE)
- 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.
Inclusion: 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: 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.