A Phase I Study of BKM120, Administered Orally in Adult Chinese Patients With Advanced Solid Tumors
This is a single arm study, with a starting dose of BKM120 at 80mg/day. Two dose levels:
80mg/day and 100mg /day will be tested in the dose escalation phase. At least 3 patients
will be enrolled at each dose level and at least 6 evaluable patients required to be treated
at the recommended Phase II dose(RP2D)/MTD dose. After dose escalation the 80mg/day and the
100mg /day dose levels will be expanded to evaluate up to approximately a total of 15
patients each (if 100mg is determined as the RP2D/MTD).
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose Limiting Toxicity (DLT)
An adaptive Bayesian logistic regression model (BLRM) for dose escalation with overdose control will guide the dose escalation. The recommended dose is the one with the highest posterior probablity of DLT in the target interval(16%,33%) among the doses fulfilling the overdose criterion that there is less than 25 % chance of excessive toxicity. A clinical synthesis of the available toxicity information including adverse event that are not DLTs, Pharmacokinetics, Pharmacodynamics, efficacy as well as the recommnendations from the BLRM will be used to determine the dose.
During Cycle 1 (28 days)
China: Food and Drug Administration