BKM120 + Carboplatin + Paclitaxel for Patients With Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

February 15, 2011

Primary Completion Date

March 29, 2017

Study Completion Date

March 29, 2017

Conditions
Solid Tumors
Interventions
DRUG

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.

DRUG

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.

DRUG

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

DRUG

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

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

collaborator

Sai Life Sciences

UNKNOWN

lead

Memorial Sloan Kettering Cancer Center

OTHER