Olaparib: Phase I started

Cancer Research U.K. (London, U.K.) began an open-label, dose-escalation, U.K. Phase I trial to evaluate AstraZeneca's oral olaparib in combination with temozolomide in patients with relapsed GBM that requires surgery. In the first part of the trial, 6 patients will receive twice-daily olaparib for 3 days before surgery to determine if olaparib crosses the blood-brain barrier. In the second part of the trial, about 15 patients will receive escalating doses of olaparib once or twice daily in combination with once-daily temozolomide on days 1-42 of an 8-week cycle for 3 cycles in the absence of disease progression or unacceptable toxicity. The trial will enroll 10 additional patients in an expansion cohort to receive olaparib at the MTD in combination with temozolomide. Patients will be eligible to receive up to 3 additional courses of olaparib in the absence of disease progression. ...