Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitor BMS-986158 in Pediatric Cancer

Official Title

Phase 1 Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitor BMS-986158 in Pediatric Cancer

Summary:

This research study is studying an investigational drug called BMS-986158 as a possible treatment for pediatric solid tumours, lymphoma, or brain tumours.

Trial Description

Primary Outcome:

• Dose Limiting Toxicity Rate
• The Rate of Toxicities of BMS-986158

Secondary Outcome:

• Objective Response Rate
• Pharmacokinetics of BMS-986158
• Pharmacodynamics of BMS-986158
• Blood Markers of Response
• CSF Markers of Response
• Tumour Markers of Response

This is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved BMS-986158 as a treatment for any disease. BMS-986158 is currently still being studied in adults. This is the first time that BMS-986158 will be evaluated in younger children, though children 12-17 years of age may also be included in parts of adult studies of BMS-986158. Research in the laboratory has shown that BMS-986158 may have activity against cancer cells. BMS-986158 belongs to a group of drugs called Bromodomain (BRD) and Extra-Terminal Domain (BET) inhibitors. These drugs block proteins that are important in reading DNA, which is a process important for cancer cells.

View this trial on ClinicalTrials.gov