Ignite Creation Date:
2024-05-06 @ 1:06 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03936465
Status:
COMPLETED
Last Update Posted:
2024-03-21
First Post:
2019-04-30
Brief Title:
Study of the Bromodomain BRD and Extra-Terminal Domain BET Inhibitors BMS-986158 and BMS-986378 in Pediatric Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase 1 Study of the Bromodomain BRD and Extra-Terminal Domain BET Inhibitors BMS-986158 and BMS-986378 CC-90010 in Pediatric Cancer
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Arm 1 of this research study is studying an investigational drug called BMS-986158 as a possible treatment for pediatric solid tumors or lymphoma Arm 2 of this research study is studying an investigational drug called BMS-986378 also known as CC-90010 as a possible treatment for pediatric brain tumors or pediatric tumors that have spread to the brain
Detailed Description:
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 US Food and Drug Administration has not approved BMS-986158 or BMS-986378 as a treatment for any disease
BMS-986158 and BMS-986378 are currently still being studied in adults This is the first time that BMS-986158 or BMS-986378 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 and BMS-986378 may have activity against cancer cells These drugs belong 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
The FDA the US Food and Drug Administration has not approved BMS-986158 or BMS-986378 as a treatment for any disease
BMS-986158 and BMS-986378 are currently still being studied in adults This is the first time that BMS-986158 or BMS-986378 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 and BMS-986378 may have activity against cancer cells These drugs belong 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None