Breast Cancer Clinical Trial
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
Summary
Comparison of olaparib vs. physician's choice of single agent standard of care non-platinum based chemotherapy in patients with germline Breast Cancer susceptibility gene (gBRCA) mutated ovarian cancer who have progressed at least 6 months after the last platinum based chemotherapy. Patient should have received at least 2 prior lines of platinum based chemotherapy. The aim of the study is to assess the efficacy and safety of olaparib tablets.
Full Description
This open label, randomised, controlled, multi-centre study will assess the efficacy and safety of single agent olaparib vs. standard of care, based on physician's choice of single agent chemotherapy ( i.e paclitaxel, or topotecan, or pegylated liposomal doxorubicin, or gemcitabine) in platinum sensitive or partially platinum sensitive relapsed ovarian cancer patients who carry germline deleterious or suspected deleterious BRCA mutation and who have received at least 2 prior lines of platinum based chemotherapy. 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.
Eligibility Criteria
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).
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There are 93 Locations for this study
Birmingham Alabama, 35233, United States
Mobile Alabama, 36604, United States
Sacramento California, 95817, United States
San Francisco California, 94118, United States
Aurora Colorado, 80045, United States
Littleton Colorado, 80120, United States
Hartford Connecticut, 06106, United States
Fort Gordon Georgia, 30905, United States
Covington Louisiana, 70433, United States
Towson Maryland, 21204, United States
Detroit Michigan, 48201, United States
Albany New York, 12208, United States
Mineola New York, 11501, United States
Chapel Hill North Carolina, 27599, United States
Columbus Ohio, 43210, United States
Springfield Oregon, 97477, United States
Abington Pennsylvania, 19001, United States
Knoxville Tennessee, 37920, United States
Nashville Tennessee, 37232, United States
Bedford Texas, 76022, United States
Houston Texas, 77030, United States
Milwaukee Wisconsin, 53226, United States
Berazategui , B1884, Argentina
Caba , C1280, Argentina
Ciudad de Buenos Aires , C1180, Argentina
Cordoba , 5000, Argentina
La Plata , B1897, Argentina
San Miguel de Tucumán , T4000, Argentina
Gent , 9000, Belgium
Leuven , 3000, Belgium
Ijui , 98700, Brazil
Passo Fundo , 99010, Brazil
Porto Alegre , 90035, Brazil
Porto Alegre , 90610, Brazil
Rio de Janeiro , 22793, Brazil
Sao Paulo , 01246, Brazil
Sao Paulo , 01317, Brazil
São José do Rio Preto , 15090, Brazil
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H2L 4, Canada
Hradec Kralove , 500 0, Czechia
Ostrava-Poruba , 708 5, Czechia
Praha 2 , 128 0, Czechia
Zlin , 762 7, Czechia
Budapest , 1088, Hungary
Budapest , 1115, Hungary
Budapest , 1122, Hungary
Debrecen , 4032, Hungary
Győr , 9024, Hungary
Miskolc , 3526, Hungary
Afula , 18101, Israel
Haifa , 31096, Israel
Holon , 58100, Israel
Jerusalem , 91031, Israel
Jerusalem , 91120, Israel
Petah Tikva , 49414, Israel
Ramat Gan , 52621, Israel
Rehovot , 76610, Israel
Tel Hashomer , 52621, Israel
Tel-Aviv , 64239, Israel
Zerifin , 70300, Israel
Meldola , 47014, Italy
Messina , 98158, Italy
Milano , 20132, Italy
Milano , 20133, Italy
Milano , 20141, Italy
Napoli , 80131, Italy
Roma , 00144, Italy
Roma , 00168, Italy
Goyang-si , 10408, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 06273, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 138-7, Korea, Republic of
Seoul , 139-7, Korea, Republic of
Mexico , 07760, Mexico
Mexico , 6760, Mexico
Oaxaca , 68000, Mexico
Gdańsk , 80-21, Poland
Grzepnica , 72-00, Poland
Lublin , 20-09, Poland
Olsztyn , 10-56, Poland
Poznan , 60-56, Poland
Warszawa , 02-78, Poland
Åódź , 93-51, Poland
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 08907, Spain
Córdoba , 14004, Spain
Gerona , 17007, Spain
Granada , 18014, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
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