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BET Inhibitors for Pediatric Solid Cancers
Study Summary
This trial is testing two different drugs to treat different types of pediatric tumors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 1 & 2 trial • 83 Patients • NCT02419417Trial Design
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Who is running the clinical trial?
Media Library
- My cancer has a high level of the MYCN gene.I have not taken certain medications, grapefruit, Seville oranges, NSAIDs, oral anticoagulants, heparins, or other investigational drugs recently.My cancer involves a change in the MYC or MYCN gene.I have recovered from side effects of previous cancer treatments, except for issues related to organ function.I can swallow pills without any issues.My cancer was confirmed through a biopsy or surgery when it came back or got worse.My cancer was confirmed through a biopsy or surgery, and it has specific genetic features.My cancer has a high level of the MYC gene.My brain tumor has specific genetic changes like MYC/N amplification or BRD4 changes.My cancer is confirmed by biopsy or surgery and is not in the brain.I have a history of HIV, hepatitis B, or hepatitis C.I have a confirmed primary brain tumor or untreated brain metastases.My body surface area is less than 0.3 m2, except for specific doses where it must be over 0.71 m2.My cancer has specific genetic changes like MYC/N amplification or BRD4 changes.I do not have stomach or intestine problems that could affect medication absorption.I am mostly able to care for myself and carry out daily activities.My disease has returned or isn't responding to treatment, and there are no cure options left.I am 21 years old or younger and can swallow pills.I have been diagnosed with the condition required for the trial.My condition has returned or hasn't responded to treatment, and there are no curative options left.My organs, including my liver, kidneys, heart, and bone marrow, are functioning well.You are pregnant.I have no allergies to BMS-986158, BMS-986378, or similar drugs.I have completed required waiting periods after my last cancer treatment or surgery.I am 21 years old or younger.I have had a solid organ or bone marrow transplant.My body surface area is less than 0.65 square meters.I do not have a primary or metastatic brain tumor.I am mostly able to carry out daily activities.I (or my guardian) can understand and agree to the study's consent form.I do not have any uncontrolled illnesses.You are currently breastfeeding.You must have a medical condition that can be measured or evaluated by the study team.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
- Group 1: Arm 1 Cohort B
- Group 2: Arm 1 Cohort A
- Group 3: Arm 2 Cohort B
- Group 4: Arm 2 Cohort A
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
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."
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."
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."
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."
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)."
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."
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."
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."
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