Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status
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.
- 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.
- 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.
Principal Investigator Name
Colleen McCormick, MD
Oncology Clinical Research
Wednesday, January 27, 2021 12:56:59 PM