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Bromodomain and Extra-Terminal Domain Inhibitor

BET Inhibitors for Pediatric Solid Cancers

Phase 1
Waitlist Available
Led By Steven G. DuBois, MD, MS
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
MYCN amplification or high copy number gain
Translocation involving MYC or MYCN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing two different drugs to treat different types of pediatric tumors.

Who is the study for?
This trial is for children and young adults up to 21 years old with certain types of cancer, including solid tumors, lymphoma, or brain tumors. They must have relapsed or refractory disease where standard treatments are ineffective. Participants need normal organ function and the ability to swallow pills. Those who've had recent other treatments or surgeries must wait specific periods before joining.Check my eligibility
What is being tested?
The study tests two investigational drugs: BMS-986158 for pediatric solid tumors or lymphoma (Arm 1), and BMS-986378 for pediatric brain tumors or those that have spread to the brain (Arm 2). It aims to see if these drugs are safe and effective in treating these conditions.See study design
What are the potential side effects?
While not specified here, side effects may include typical reactions seen with cancer therapies such as nausea, fatigue, blood count changes, liver issues, allergic reactions similar to components of the drugs being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has a high level of the MYCN gene.
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My cancer involves a change in the MYC or MYCN gene.
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I can swallow pills without any issues.
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My cancer has a high level of the MYC gene.
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My cancer is confirmed by biopsy or surgery and is not in the brain.
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My cancer has specific genetic changes like MYC/N amplification or BRD4 changes.
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I am mostly able to care for myself and carry out daily activities.
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My disease has returned or isn't responding to treatment, and there are no cure options left.
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I am 21 years old or younger and can swallow pills.
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My condition has returned or hasn't responded to treatment, and there are no curative options left.
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My organs, including my liver, kidneys, heart, and bone marrow, are functioning well.
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I have completed required waiting periods after my last cancer treatment or surgery.
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I am 21 years old or younger.
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I am mostly able to carry out daily activities.
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I (or my guardian) can understand and agree to the study's consent form.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity Rate
The Rate of Toxicities from Protocol Therapy
Secondary outcome measures
Blood Markers of Response
CSF Markers of Response
Objective Response Rate
+3 more

Side effects data

From 2021 Phase 1 & 2 trial • 83 Patients • NCT02419417
100%
Fatigue
75%
Decreased appetite
75%
Vomiting
75%
Nausea
50%
Headache
50%
Thrombocytopenia
50%
Constipation
50%
Dyspnoea
25%
Hypokalaemia
25%
Flank pain
25%
Cough
25%
Early satiety
25%
Insomnia
25%
Pain in extremity
25%
Hot flush
25%
Pneumonia
25%
Dehydration
25%
Paraesthesia
25%
Pain in jaw
25%
Candida infection
25%
Lymphocyte count decreased
25%
Abdominal discomfort
25%
Back pain
25%
Arthralgia
25%
Malignant neoplasm progression
25%
Lacrimation increased
25%
Weight decreased
25%
Muscle spasms
25%
Oropharyngeal pain
25%
Dyspepsia
25%
Abdominal pain
25%
Diarrhoea
25%
Dry mouth
25%
Urinary tract infection
25%
Small intestinal obstruction
25%
Abdominal distension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1 Schedule A - BMS-986158 1.25 mg
Part 1 Schedule B - BMS-986158 3 mg
Part 1 Schedule A - BMS-986158 3 mg
Part 2 Schedule A
Part 1 Schedule B - BMS-986158 2 mg
Part 1 Schedule A - BMS-986158 2 mg
Part 1 Schedule A - BMS-986158 4.5 mg
Part 1 Schedule A - BMS-986158 0.75 mg
Part 1 Schedule C - BMS-986158 2 mg
Part 1 Schedule C - BMS-986158 3 mg
Part 1 Schedule C - BMS-986158 4.5 mg

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm 2 Cohort BExperimental Treatment1 Intervention
Patients will receive BMS-986378 (also known as CC-90010) monotherapy orally for 4 days every 28 days. Patients with relapsed or refractory CNS tumors or CNS metastatic tumors that have defined molecular features predicted to increase sensitivity to BET inhibition
Group II: Arm 2 Cohort AExperimental Treatment1 Intervention
Patients will receive BMS-986378 (also known as CC-90010) monotherapy orally for 4 days every 28 days. Patients with relapsed or refractory CNS tumors or CNS metastatic tumors
Group III: Arm 1 Cohort BExperimental Treatment1 Intervention
Patients will receive BMS-986158 monotherapy orally for 5 days on / 2 days off per week in 28-day cycles. Patients with relapsed or refractory solid tumors or lymphoma that have defined molecular features predicted to increase sensitivity to BET inhibition
Group IV: Arm 1 Cohort AExperimental Treatment1 Intervention
Patients will receive BMS-986158 monotherapy orally for 5 days on / 2 days off per week in 28-day cycles. Patients with unselected relapsed or refractory solid tumors or lymphoma
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-986158
2015
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

Stand Up To CancerOTHER
51 Previous Clinical Trials
40,295 Total Patients Enrolled
1 Trials studying Lymphoma
59 Patients Enrolled for Lymphoma
Dana-Farber Cancer InstituteLead Sponsor
1,080 Previous Clinical Trials
340,889 Total Patients Enrolled
59 Trials studying Lymphoma
2,345 Patients Enrolled for Lymphoma
Steven G. DuBois, MD, MSPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

BMS-986158 (Bromodomain and Extra-Terminal Domain Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03936465 — Phase 1
BMS-986158 (Bromodomain and Extra-Terminal Domain Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03936465 — Phase 1
Lymphoma Research Study Groups: Arm 1 Cohort B, Arm 1 Cohort A, Arm 2 Cohort B, Arm 2 Cohort A
Lymphoma Clinical Trial 2023: BMS-986158 Highlights & Side Effects. Trial Name: NCT03936465 — Phase 1
~1 spots leftby Jul 2024
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