45
Participants
Start Date
February 15, 2011
Primary Completion Date
March 29, 2017
Study Completion Date
March 29, 2017
BKM120 days 1 - 21 plus paclitaxel + carboplatin
Patients will receive oral daily BKM120 (days 1 - 21, per dose escalation scheme) plus paclitaxel (175 mg/m2 intravenously, day 1) + carboplatin (AUC 5 intravenously, day 1)on a 21-day cycle. Pegfilgrastim (6 mg/subcutaneously) will be administered on day 2 of each cycle.
BKM120 (days 1 - 28, ) plus paclitaxel + carboplatin
Patients will receive oral daily BKM120 (days 1 - 28, per dose escalation scheme) plus paclitaxel (80 mg/m2 intravenously, days 1, 8 and 15) + carboplatin (AUC 5 intravenously, day 1) on a 28-day cycle.
BKM120 (days 1-21) + paclitaxel (day 1) + carboplatin (day 1)
BKM120 100 mg (days 1 - 21, per dose escalation scheme) plus paclitaxel (200 mg/m2 intravenously, day 1) + carboplatin (AUC 6 intravenously, day 1) on a 21-day cycle. After enrollment to Groups 1 and 2 has been completed and all patients in Group 1 and 2 have completed the DLT monitoring period, up to 6 additional patients will be enrolled in this EXPANSION COHORT.A
BKM120, Paclitaxel + Carboplatin
BKM120 100 mg per oral, days 1 - 21 Paclitaxel (175 mg/m2) intravenously on Day 1 Carboplatin (AUC 5) intravenously on Day 1 EXPANSION COHORT B
Memorial Sloan Kettering Cancer Center, New York
Collaborators (2)
Novartis Pharmaceuticals
INDUSTRY
Sai Life Sciences
UNKNOWN
Memorial Sloan Kettering Cancer Center
OTHER