SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01297452

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase I Study of BKM120 + Carboplatin + Paclitaxel for Patients With Advanced Solid Tumors

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.

NCT01297452 Solid Tumors

4 Interventions

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: Drug

BKM120 (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: Drug

BKM120 (days 1 - 28, ) + paclitaxel + carboplatin BKM120 (days 1 - 21) + paclitaxel + carboplatin exp B

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.A

Type: Drug

BKM120 (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 B

Type: Drug

BKM120 (days 1 - 21) + paclitaxel + carboplatin


Primary Outcomes

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 years

Measure: EXPANSION COHORT A:To evaluate the safety and tolerability of daily oral BKM120 (100 mg) + paclitaxel (200 mg/m2) + carboplatin (AUC 6), both given intravenously (IV) on day 1 of a 21-day cycle, with pegfilgrastim support

Time: 2 years

Measure: EXPANSION COHORT B: To obtain a preliminary description of efficacy of the regimen established in Group 1 among patients with tumors harboring PTEN mutation or homozygous deletion.

Time: 2 years

Secondary Outcomes

Description: 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 years

Description: 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 years

Description: 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 years

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 P13K

Exclusion Criteria: - Patients who have received prior treatment with a P13K inhibitor. --- P13K ---



HPO Nodes