Gynecologic Cancer D0816C00010-SOLO 3

April 26, 2017

Sponsor: AstraZeneca

Number: D0816C00010-SOLO 3

Comparison of Olaparib vs. physician's choice of single agent standard of care non-platinum based chemotherapy. This study is for patients with germline Breast Cancer susceptibility gene (gBRCA) mutated ovarian cancer who have progressed at least 6 months after the last platinum based chemotherapy.  BRCA  genes are known as tumor suppressor genes or anti-oncogenes. 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.

Who’s eligible:

  • Patients must have histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer. Patients must be 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.
  • The patient must have documented germline mutation (a gene change in a body's reproductive cell) 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)
  • There must be 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.
  • This study is for women age 18 and older

Available at: The Hospital of Central Connecticut, Hartford Hospital.

Cancer Clinical Research Office