Project 2: Combination ATR and PARP Inhibitor (CAPRI) Trial With AZD6738 and Olaparib in Recurrent Ovarian Cancer (CAPRI) PI: Dr. Fiona Simpkins
ClinicalTrials.gov Identifier: NCT03462342
This study will determine if using Olaparib in combination with AZD6738 is safe and tolerable and also determine the objective response rate and progression free survival of combination of AZD 6738 and Olaparib in women with recurrent ovarian cancer in distinct platinum-sensitive and platinum-resistant cohorts.
Women 18 years or older, who have recurrent ovarian cancer will be enrolled in this study. After consenting to participate in this trial, they will undergo a screening process which will involve medical exam and blood work. If found eligible to participate in the trial, they will be given olaparib to be taken on all 28 days of the cycle and investigational AZD 6738 from days 1-7. For the first cycle, the subject will need to come in every week for lab tests and physical exam – this will help the treating physician determine an adverse event as soon as it happens. After that, patients are expected to come in every month at the end of each cycle (each cycle is 28 days).
Patients will undergo scans for tumor assessments every 2 cycles and if stable disease or response to therapy is documented after cycle 4, imaging will continue every 3 cycles thereafter.
Project 4: Clinical Trial of Combined Fostamatinib and Paclitaxel in Ovarian Cancer PI: Dr. Stephanie Gaillard
ClinicalTrials.gov Identifier: NCT03246074
This is a phase I, open-label, non-randomized multicenter dose-escalation study with the primary objective to determine the maximally tolerated dose (MTD) of fostamatinib when administered with weekly paclitaxel in women with recurrent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer.
Between 8 and 18 adult female subjects will be enrolled and receive weekly paclitaxel in combination with increasing doses of fostamatinib. There will be three dosing intervals of fostamatinib (100 mg bid, 150 mg bid, and 200mg bid) selected based on prior phase I studies of single agent fostamatinib. Dose-escalation will follow a modified toxicity probability interval (mTPI) design. In this study, up to 18 adult female subjects will be enrolled and receive weekly paclitaxel in combination with fostamatinib at the MTD of the combination; at least 6 patients with receive fostamatinib plus paclitaxel at the MTD.