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Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments
Bu çalışma, germline BRCA1 veya BRCA2 mutasyonu taşıyan, en az 2 platin tedavisi almış ve son platin tedavisinden en az 6 ay sonra ilerleyen nükseden yüksek dereceli yumurtalık kanseri (ovarian cancer) hastalarında Olaparib ilacını tek ajan kemoterapiyle karşılaştırıyor. Doğrulanmış BRCA mutasyonu olan 18 yaş üstü hastalar dahil edilmiştir. Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
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Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Patients must be ≥ 18 years of age * Patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer. Patients are eligible to undergo BRCA testing even if they have not yet had recurrence or progression of disease \>6 months (\>/=183 days) after completion of their last platinum therapy. * Documented germline mutation in Breast Cancer susceptibility genes: BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function) * At least one lesion that can be accurately assessed at baseline by CT/MRI and is suitable for repeated assessment. * Patients must have received at least 2 prior platinum based lines of chemotherapy - Patients must be partially platinum sensitive or platinum sensitive * Patients must be suitable to start treatment with single agent chemotherapy based on physician's choice * Patients must have normal organ and bone marrow function measured within 28 days of randomisation, * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Patients must have a life expectancy ≥ 16 weeks * Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing. Exclusion Criteria: * BRCA 1 and/or BRCA2 mutations that are considered to be non detrimental * Exposure to any investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation * Any previous treatment with a Polyadenosine 5'diphosphoribose polymerisation (PARP) inhibitor, including olaparib. * Patients who have platinum resistant or refractory disease * Patients receiving any systemic chemotherapy within 3 weeks prior to first dose of study treatment * Previous single agent exposure to the selected chemotherapy regimen for randomisation. - Prior malignancy in the last 5 years, unless curatively treated and recurrence free (few exceptions apply).