Efficacy and Safety Study of Cediranib in Combination With Olaparib in Patients With Recurrent Pl… (NCT02889900) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety Study of Cediranib in Combination With Olaparib in Patients With Recurrent Platinum-Resistant Ovarian Cancer
United States62 participantsStarted 2017-01-17
Plain-language summary
This is an open label, single arm, multi-center study to assess the efficacy and safety of the combination of cediranib and olaparib tablets in platinum-resistant relapsed high grade serous, high grade endometroid or clear cell ovarian, fallopian tube or primary peritoneal carcinoma patients who have received at least 3 prior lines of chemotherapy and who do not carry deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA) mutations.
Who can participate
Age range18 Years – 120 Years
SexFEMALE
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Inclusion criteria
✓. Ability and willingness to provide written informed consent, and to comply with the requirements of the protocol
✓. Females aged ≥18 years with previous histologically proven diagnosis of high grade serous, high grade endometroid or clear cell ovarian cancer, fallopian tube or primary peritoneal carcinoma
✓. No evidence of deleterious or suspected deleterious germline mutation in BRCA1 or BRCA2 genes
✓. Recurrent platinum-resistant disease, defined as disease progression within 6 months (182 days) of the last receipt of platinum-based chemotherapy
✓. CT/MRI evidence of measurable disease as per RECIST 1.1 defined as at least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) and which is suitable for accurate repeated measurements
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
✓. Life expectancy ≥12 weeks
✓. Prior receipt of antiangiogenic treatment, including but not limited to bevacizumab, is optional. If used, it can be used in the first line or recurrent setting.
Exclusion criteria
✕. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
✕. Previous enrollment in the present study.
What they're measuring
1
Mean Objective Response Rate (ORR) by Independent Central Review (ICR) Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Timeframe: From baseline to primary analysis DCO (8 months after last patient received their first dose of IPs). RECIST assessments were performed at baseline and every 8 weeks (+/- 1 week) after first doses of IPs until disease progression.
. Exposure to any IP during the last 4 weeks prior to enrollment.
✕. Previous treatment with PARP inhibitor. For this study, BSI-201 (iniparib) is not considered as PARPi
✕. Recent cancer-directed therapies: Radiotherapy (RT) within 4 weeks, chemotherapy or other systemic anti-cancer therapy within 4 weeks, or prior anti-angiogenic treatment (e.g., bevacizumab) within 6 weeks prior to starting treatment
✕. Cancer antigen-125 (CA-125) only disease without RECIST 1.1 measurable disease
✕. Major surgical procedure within 2 weeks prior to starting treatment; patients must have recovered from any effects of any major surgery and surgical wound should have healed prior to starting treatment
✕. Clinically significant signs and/or symptoms of bowel obstruction within 3 months prior to starting treatment