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Spots Global Cancer Trial Database for Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 in Pediatric Cancer

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Trial Identification

Brief Title: Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 in Pediatric Cancer

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

Study ID: NCT03936465

Study Description

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 U.S. 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.

Eligibility

Minimum Age: 1 Year

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Dana Farber Cancer Institute, Boston, Massachusetts, United States

C.S. Mott Children's Hospital, Ann Arbor, Michigan, United States

Duke University Medical Center, Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Seattle Children's Hospital, Seattle, Washington, United States

Hospital for Sick Children, Toronto, Ontario, Canada

Contact Details

Name: Steven G. DuBois, MD, MS

Affiliation: Dana-Farber Cancer Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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