Study to Assess Safety, Tolerability and Preliminary Efficacy of BKM120, PI3K Kinase Inhibitor, With Advanced Leukemias
|ClinicalTrials.gov Identifier: NCT01396499|
Recruitment Status : Completed
First Posted : July 18, 2011
Last Update Posted : November 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: BKM120||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Open-label Study to Assess the Safety, Tolerability and Preliminary Efficacy of BKM120, PI3K Kinase Inhibitor, in Patients With Advanced Leukemias|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Oral BKM120 starting dose 80 mg once daily.
Starting dose 80 mg tablets by mouth daily for a 28 day cycle.
- Maximum Tolerated Dose of BKM 120 [ Time Frame: 28 days, Cycle 1 ]
Maximum tolerated dose (MTD) defined as highest dose in which 1/6 or less subjects experience a dose limiting toxicity (DLT) during the first course of treatment.
Toxicity assessed using the NCI Common Toxicity Criteria for Adverse Events, version 4.0.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396499
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Marina Konopleva, MD, PHD||M.D. Anderson Cancer Center|