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AstraZeneca D0816L00003


Clinical Trial Title

Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status

Trial Status

Closed to Enrollment

Start Date

April 27, 2017

Trial Type

Cancer - Adult Oncology

Specific Condition

Ovarian Cancer


This is a non-randomized, open-label study to assess olaparib tablets as a treatment for subjects with different homologous recombination deficiency (HRD) tumor status and with platinum-sensitive, relapsed, high-grade serous or high-grade endometrioid ovarian cancer. Subjects should have received at least 1 prior line of platinum-based chemotherapy.

Eligibility Criteria

  • Age >= 18
  • Histologically diagnosed relapsed high-grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer).
  • Must have received at least 2 prior platinum-based lines of chemotherapy for ovarian cancer.
  • Must be partially-platinum-sensitive (defined as progression 6 to 12 months after the end of the last platinum-based chemotherapy) or platinum-sensitive (defined as progression > 12 months after the end of the last platinum-based chemotherapy).
  • ECOG performance status 0 to 1.
  • Must have a life expectancy >= 16 weeks.
  • Postmenopausal or evidence of non-childbearing status for women of childbearing potential.

Exclusion Criteria

  • Involvement in the planning and/or conduct of the study.
  • Exposure to any investigational product (IP) within 30 days or 5 half-lives (whichever is longer) prior to start of study treatment.
  • Any previous treatment with a PARP inhibitor, including olaparib.
  • Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer; curatively treated in situ cancer of the cervix; ductal carcinoma in situ; Stage 1, grade 1 endometrial carcinoma; or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for at least 5 years. Subjects with a history of localized triple negative breast cancer may be eligible, provided they completed their adjuvant chemotherapy more than 3 years prior to registration, and that the subject remains free of recurrent or metastatic disease.
  • Subjects receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment.

IRB Number

Legacy IRB

Principal Investigator Name

Colleen McCormick, MD

Contact Name

Oncology Clinical Research



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Last Updated: Wednesday, January 27, 2021 12:56:59 PM