Olaparib in Patients With Recurrent Ovarian Cancer Wild Type for Germline and Somatic BRCA 1 and … (NCT04091204) | Clinical Trial Compass
UnknownPhase 2
Olaparib in Patients With Recurrent Ovarian Cancer Wild Type for Germline and Somatic BRCA 1 and 2 Genes: The MITO 31 Translational Study
Italy200 participantsStarted 2019-07-04
Plain-language summary
The aim of the study is to explore a prognostic clinical and molecular biomarker profile in a population of BRCA wild-type recurrent high-grade ovarian cancer patients treated with olaparib as maintenance after response to a platinum based therapy as platinum sensitive recurrence treatment.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Patients must be ≥ 18 years of age
✓. Female patients with histologically diagnosed relapsed high grade ovarian cancer (including primary peritoneal and /or fallopian tube cancer)
✓. Documented absence of somatic and germline mutations of BRCA1 or BRCA2 genes, that is predicted to be deleterious or suspected deleterious
✓. ECOG Performance Status of 0-2
✓. Patients must have a life expectancy of at least 16 weeks
✓. Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements
✓. Availability of tumor and blood samples for molecular analyses
✓. Patients who have received at least 2 previous line of platinum containing therapy prior to randomization
Exclusion criteria
✕. History or evidence of synchronous primary endometrial carcinoma, unless all of the following criteria related to the endometrial carcinoma are met:
✕. Other malignancy within the last 5 years, except for adequately treated non melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinomna in situ (DCIS), stage 1, grade 1 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for \> 5years
. Resting ECG with QTc \> 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome
✕. Participation in another clinical study with an investigational product during the chemotherapy course immediately prior to randomization
✕. Patients receiving any systemic radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
✕. Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks
✕. Concomitant use of known strong (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort ) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents
✕. Persistent toxicities \[\>Common Terminology Criteria for Adverse Event (CTCAE) grade 2)\] caused by previous cancer therapy, excluding alopecia