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Title
Status

 

BMS BET 19-040 - Phase 1 Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitor BMS-986158 in Pediatric Cancer

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BMS BET 19-040 - Phase 1 Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitor BMS-986158 in Pediatric Cancer

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DiagnosisChildhood Solid Tumor, Lymphoma, Pediatric Brain Tumor, Other brain tumors, Other solid tumours, Non-Hodgkin lymphomaStudy StatusClosed
PhaseI
AgeChild, Adult - (1 Year to 21 Years)RandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment Administrationoral (capsule)
Last Posted Update2024-03-18
ClinicalTrials.gov #NCT03936465
International Sponsor
Dana-Farber Cancer Institute
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This study is to evaluate the drug called BMS-986158 as a possible treatment for pediatric solid tumors, lymphoma, or brain tumors. BMS-986158 belongs to a group of drugs called "Bromodomain (BRD) and Extra-Terminal Domain (BET) inhibitors". These drugs block proteins from the BET family that are important in reading part of the DNA involved in apoptosis and cell cycle progression. It is expected to slow or stop the growth of cancer cells.

The aim of this phase I study is to evaluate the dose, safety, tolerability, antitumor activity and other pharmacologic characteristics of BMS-986158 in children with refractory or relapsed pediatric solid tumors, lymphoma, or brain tumors for which no standard therapy is available or for which the subject is not eligible for the existing therapy.

Inclusion Criteria
  • Age ≤ 21 years at time of enrollment.
  • All patients must be able to swallow intact capsules.

  • Participants must have evaluable or measurable disease and must have disease that is relapsed or refractory and for which standard curative measures do not exist or are no longer effective.

  • Disease genetic alterations: MYCN amplification or high copy number gain, translocation involving MYC or MYCN, translocation involving BRD4 or BRD3

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.