The purpose of this study is to find out the good and bad effects that occur when BKM120 is added to standard chemotherapy with carboplatin and paclitaxel.
Name: BKM120 days 1 - 21 plus paclitaxel + carboplatin
Description: 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.Type: DrugBKM120 (days 1 - 21) + paclitaxel + carboplatin
Name: BKM120 (days 1 - 28, ) plus paclitaxel + carboplatin
Description: 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.Type: DrugBKM120 (days 1 - 21) + paclitaxel + c BKM120 (days 1 - 21) + paclitaxel + carboplatin exp B BKM120 (days 1 - 28, ) + paclitaxel + carboplatin
Name: BKM120 (days 1-21) + paclitaxel (day 1) + carboplatin (day 1)
Description: 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.AType: DrugBKM120 (days 1-21) + paclitaxel (day 1) + carboplatin (day 1)
Name: BKM120, Paclitaxel + Carboplatin
Description: 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 BType: DrugBKM120 (days 1 - 21) + paclitaxel + carboplatin
Description: for patients with advanced solid tumors, BKM120 in combination with two different schedules of paclitaxel and carboplatin.
Measure: To establish the phase II recommended dose of daily oral BKM120 Time: 2 yearsDescription: Patients will be evaluated by MD at weekly clinic visits during Cycle 1, on Day 1 of subsequent cycles, and will have additional evaluations if clinically indicated. Toxicities will be assessed according to NCI common toxicity criteria (CTC) version 4.0
Measure: To describe the safety of BKM120 combined with paclitaxel and carboplatin, Time: weekly clinic visits during Cycle 1, on Day 1 of subsequent cycles,Description: when given in combination with carboplatin and paclitaxel. The area under the curve (AUC0→∞), half-life (t½), and maximum concentration (Cmax) for BKM120 will be determined by noncompartmental analysis.(except for Expansion Cohort B)
Measure: To determine the pharmacokinetic profile of daily BKM120. Time: 2 yearsDescription: there is insufficient sample size to support a formal analysis of response rate. As such, radiographic response data will be tabulated and presented in descriptive form.
Measure: To describe and tabulate the radiographic response rate of BKM120 in combination with carboplatin and paclitaxel, Time: 2 yearsDescription: we will calculate the proportion of cases with positive staining of PTEN along with a 95% confidence interval, using the Clopper and Pearson method for exact small sample inference. For Sequenom Analysis, we will calculate the proportion of cases that are positive for each mutation
Measure: Correlative Tissue Studies Time: 2 yearsAllocation: Non-Randomized
Parallel Assignment
There is one SNP
Exclusion Criteria: - Patients who have received prior treatment with a P13K inhibitor. --- P13K ---