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
Condition: Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: OLAPARIB; Single agent chemotherapy
Intervention description: 300 mg olaparib tablets taken orally twice daily. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria.; Treatment of relapsed disease with single agent chemotherapy based on physician's choice of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria
Intervention MeSH terms: Olaparib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)
Enrollment: 266.0
Sex: Female
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: BRCA, ovarian, platinum, chemotherapy,

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.
    

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).