Back to Search Results
Back to Results
Gynecologic
General Information
Study Name:
Non-Randomized, Open-Label Phase II Study to Assess Olaparib Tablets as a Treatment for Subjects with Different HRD Tumor Status and with Platinum-Sensitive, Relapsed, High-Grade Serous or High-Grade Endometrioid Ovarian, Fallopian Tube, or Primary Peritoneal Cancer That Have Received at Least 1 Prior Line of Chemotherapy- Astra Zeneca
Age Group:
Adult
Protocol Number:
NCT02983799
Background Information:
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.
Offered at:
3289 Woodburn Rd
Annandale, Virginia 22003
Eligibility Information
Provision of written signed informed consent prior to any study specific procedures.
Female subjects with histologically diagnosed relapsed high-grade serous or high-grade endometrioid ovarian cancer;
At least 1 lesion (measurable by RECIST v1.1) that can be accurately assessed at baseline by computed tomography (CT)/magnetic resonance imaging (MRI) and is suitable for repeated assessment;
Subjects must have received at least 1 prior platinum-based line of chemotherapy for ovarian cancer. Note: There is no limit on the number of lines of chemotherapy;
Subjects 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);
Subjects must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment
Additional eligibility in protocol
Ineligibility Information
Involvement in the planning and/or conduct of the study (applies to both AstraZeneca Representative staff and/or staff at the study site);
Previous enrollment in the present 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;
Subjects who have platinum-resistant or refractory disease defined as progression during or within 6 months of the last platinum-based chemotherapy;
Other malignancy within the last 5 years (few exceptions apply)
Additional ineligibility in protocol
Contact Information
Contact Name:
Catherine D’Reaux, RN, BSN, OCN
Contact Phone:
703-208-6630
Contact Email:
catherine.dreaux@inova.org
Additional information can be found at
https://clinicaltrials.gov/ct2/show/NCT02983799