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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 was confirmed through a biopsy or surgery when it came back or got worse.

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My cancer was confirmed through a biopsy or surgery, and it has specific genetic features.

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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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I have been diagnosed with the condition required for the trial.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

70%

Diarrhoea

60%

Thrombocytopenia

40%

Dry skin

30%

Fatigue

30%

Decreased appetite

30%

Malignant neoplasm progression

30%

Nausea

20%

Cough

20%

Hypokalaemia

20%

Hypomagnesaemia

20%

Vomiting

20%

Asthenia

20%

Pruritus

20%

Pain

10%

Rash maculo-papular

10%

Haemorrhage intracranial

10%

Neck pain

10%

Pneumonia

10%

Hypocalcaemia

10%

Rash

10%

Confusional state

10%

Small intestinal obstruction

10%

Dysgeusia

10%

Vision blurred

10%

Abdominal infection

10%

Arthritis

10%

Weight decreased

10%

Arthralgia

10%

Dehydration

10%

Anaemia

10%

Chest discomfort

10%

Herpes zoster

10%

Influenza

10%

Upper respiratory tract infection

10%

Hyponatraemia

10%

Groin pain

10%

Neuropathy peripheral

10%

Dysphonia

10%

Dyspnoea

10%

Atrial flutter

10%

Abdominal pain

10%

Dry mouth

10%

Neutropenia

100%

80%

60%

40%

20%

Study treatment Arm

Part 1 Schedule A - BMS-986158 3 mg

Part 1 Schedule B - BMS-986158 3 mg

Part 2 Schedule A

Part 1 Schedule A - BMS-986158 1.25 mg

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

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,078 Previous Clinical Trials

340,831 Total Patients Enrolled

59 Trials studying Lymphoma

2,345 Patients Enrolled for Lymphoma

Stand Up To CancerOTHER

51 Previous Clinical Trials

40,253 Total Patients Enrolled

1 Trials studying Lymphoma

59 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 A, Arm 1 Cohort B, Arm 2 Cohort B, Arm 2 Cohort A

Lymphoma Clinical Trial 2023: BMS-986158 Highlights & Side Effects. Trial Name: NCT03936465 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical facilities are conducting this research study?

"Currently, 6 distinct clinical sites are signing up participants for the trial. These include Seattle, Cincinnati and Boston as well as 3 other centres. To reduce travel burden it may be useful to choose a medical centre near you if you wish to take part in this study."

Answered by AI

To what population is this research endeavor open?

"This clinical trial seeks 66 individuals with lymphatic malignancies, aged 1 to 21 years old. To be included in this research project, participants must satisfy the following: Be of or below legal age at enrolment; demonstrate evaluable/measurable disease (see Section 11); present a relapsed or unresponsive condition for which no standard curative treatments are available any longer; involve MYC and/or MYCN gene translocations; For Arm 1 Cohort 1A - biopsy from recurrence/progression is essential if feasible, though tissue samples prior diagnosis may still be considered after consultation with the Principal Investigator."

Answered by AI

Is this trial accepting new participants?

"The current status of this trial is recruiting, per the records available on clinicaltrials.gov. The study was first published in September 2019 and last updated in December 2021."

Answered by AI

How hazardous is exposure to BMS-986158 for individuals?

"With only limited clinical evidence of efficacy and safety, our team at Power assigned BMS-986158 a score of 1."

Answered by AI

What is the main purpose of this research endeavor?

"This two-year medical trial seeks to evaluate the Dose Limiting Toxicity Rate, as well as CSF Markers of Response (i.e., ctDNA concentrations in cerebrospinal fluid), Blood Markers of Response (ctDNA levels in peripheral blood) and Pharmacokinetics of BMS-986158 (BMS-986158 plasma concentration)."

Answered by AI

Could you outline the past researches that have included BMS-986158?

"Currently, there are two open clinical trials assessing the efficacy of BMS-986158. Neither study is in its final stage yet and both have trial centres located in Badalona, New South Wales as well as 76 other sites worldwide."

Answered by AI

Could those aged 30 or above participate in this experiment?

"The criteria for this experiment mandates that participants are aged between one year and twenty-one. There is a total of 326 studies accommodating those younger than 18, while 1566 research initiatives concern patients over 65 years old."

Answered by AI

To what extent has enrollment been successful in the experimental trial?

"This clinical trial requires 66 individuals to fill the designated criteria. Participants can join from Seattle Children's Hospital in Seattle, Washington or Cincinnati Children's Hospital Medical Center located in Ohio."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Steven DuBois, MD 2019. "Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 in Pediatric Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03936465.

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