CompletedPhase 1

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

United States41 participantsStarted 2019-09-27

Plain-language 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.

Who can participate

Age range1 Year – 21 Years

SexALL

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Inclusion criteria

✓-Lipase \< upper limit of normal
✓-Diarrhea \< grade 1 by CTCAE version 5
✓-QTc \< 480 msec

Exclusion criteria

✕-Patients with a history of CNS metastatic disease that has been resected and/or radiated without evidence of active CNS disease for 3 months preceding enrollment; NOTE: patients with primary CNS tumors or solid tumors with active CNS metastases will be eligible for Arm 2.

What they're measuring

Dose Limiting Toxicity Rate

Timeframe: 28 days (first cycle)

The Rate of Toxicities from Protocol Therapy

Timeframe: 2 years

Trial details

NCT IDNCT03936465

SponsorDana-Farber Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-16

View on ClinicalTrials.gov More Solid Tumor, Childhood trials