Clinical TrialsThe James Cancer Center Columbus, OH
open for enrollment
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.
A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to assess the efficacy and safety of Olaparib Monotherapy versus Physician's Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian Cancer in Patients carrying germline BRCA1/2 Mutations.
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.
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.
Are you eligible?
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
Patients must have normal organ and bone marrow function measured within 28 days of
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.
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
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).