Effect Of Food On The Pharmacokinetics (Pk) Of Olaparib After Oral Dosing Of The Capsule Formulation.

2599 Background: The oral PARP inhibitor olaparib is well tolerated at doses ≤400 mg bid (capsule formulation) and has shown efficacy in patients (pts) with BRCA-mutated ovarian cancer (Ledermann et al ASCO 2013). This is the first study to evaluate the effect of food on olaparib PK. Methods: InPart A of this open-label, randomized, crossover Phase I trial (NCT01851265), adult pts with refractory/resistant advanced solid tumors received a single oral dose of olaparib 400 mg (8 x 50 mg capsules) in each of 3 prandial states, after (1) an overnight fast (2) a high-fat meal and (3) a standard meal (5–14 days’ washout between doses). Blood samples were taken pre-dose and regularly up to 72 h post-dose. Part B was an extension phase to further evaluate safety, where pts completing Part A could receive continuous dosing with olaparib 400 mg bid (capsules) whilst deriving clinical benefit. AE data were collected in both phases. Results: 32 pts (ECOG PS 0/1: n=30; PS 2: n=2) entered the study (female, 84%; median...