Abstract
8103 Background: Alectinib, a potent highly selective ALK inhibitor, shows good efficacy and safety for crizotinib-naive and -resistant patients (pts) with ALK-rearranged non-small cell lung cancer (NSCLC). However, each dose required 8 capsules (caps). Thus, a higher strength formulation was developed. Methods: This 2-arm crossover study (JP28927) evaluated the bioequivalence of alectinib 300 mg b.i.d. with 20 and 40 mg caps vs. 150 mg caps at steady state in ALK-rearranged NSCLC pts. Primary objectives were to evaluate bioequivalence between drug formulations and food effect with 150 mg caps; secondary objectives were to evaluate efficacy and safety. Arm 1 of Cycle 1 (30 d) consisted of 300 mg b.i.d. with 20/40 mg caps for 10 d, 150 mg caps for the next 10 d, and 150 mg caps after meals for the last 10 d. The order was different in arm 2: 150 mg caps for 10 d, 20/40 mg caps for the next 10 d, and 150 mg caps after meals for the last 10 d. After Cycle 1, to evaluate bioequivalence, pts continued alectini...
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