Spots Global Cancer Trial Database for A Phase I Study of BKM120 in Adult Chinese Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: A Phase I Study of BKM120 in Adult Chinese Patients With Advanced Solid Tumors

Official Title: A Phase I Study of BKM120, Administered Orally in Adult Chinese Patients With Advanced Solid Tumors

Study ID: NCT01626209

Conditions

Advanced Breast Cancer, Advanced Carcinomas With Squamous Cell Histology

Interventions

BKM120

Study Description

Brief Summary: Dose escalation study with a dose expansion phase, to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of two dose levels of BKM120 when administered orally.

Detailed Description: 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).