Phase I, open-label study of olaparib plus cisplatin in patients with advanced solid tumors.

1009 Background: Olaparib (AZD2281) is an oral PARP inhibitor active in advanced ovarian and breast cancers. We conducted a multicenter, dose-finding study assessing safety/ tolerability of olaparib capsules plus cisplatin in patients (pts) with advanced solid tumors (NCT00782574), for potential use in the neoadjuvant setting. Methods: Pts received 21-day(d) cycles of olaparib, continuously (Cont) or intermittently (Int), plus cisplatin on d1 of each cycle.Each cohort recruited ≥3 evaluable pts with expansion to ≥6 pts if ≥1 had a dose-limiting toxicity. The last cohort was expanded to ensure ≥6 pts completed 4 treatment cycles. Pts who completed 6 combined therapy cycles or who stopped cisplatin due to cisplatin-related toxicity could enter the monotherapy phase (up to 400 mg BID olaparib). Primary objective: safety/ tolerability of ≥4 combined cycles; secondary objectives: pharmacokinetics, antitumor activity. Results: 54 pts received treatment; pts had breast (n=42), ovarian (n=10), pancreatic (n=1) or...