A phase Ib/II trial with expansion of patients at the MTD trial of olaparib plus weekly (metronomic) carboplatin and paclitaxel in relapsed ovarian cancer patients.
5573 Background: We established the olaparib tablet maximum tolerated dose, dose limiting toxicities (DLT’s) and response to therapy of carboplatin, paclitaxel and olaparib tablet given simultaneously, reported at ASCO 2014. This abstract will include data from both the phase 1b and the phase 2 expansion. Methods: A total of 54 subjects were evaluated in this trial, 14 in phase 1b and 40 in phase 2. Eligibility required measurable disease, adequate organ function and ECOG performance status of ≤ 2. Subjects had to have failed first line platinum containing chemotherapy. BRCA testing was conducted as available. Subjects received the metronomic therapy of paclitaxel 60mg/m2 IV and carboplatin AUC 2 IV weekly, 3 weeks out of 4, and olaparib tablets at the MTD of 150 mg bid administered orally for 3 consecutive days (D1-D3), every week for each cycle. Subjects were assessed for toxicity and response according to the protocol. Subjects that reached a confirmed complete remission were transitioned to olaparib t...