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Monoclonal Antibodies
INCB7839 for Brain Cancer in Children
Phase 1
Waitlist Available
Research Sponsored by Pediatric Brain Tumor Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Off all colony-forming growth factors for at least 7 days
Failed at least 1 standard tumor-directed treatment besides surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years following last dose of incb7839.
Awards & highlights
Study Summary
This trial is testing a new drug for children with brain tumors that have come back or are growing after initial treatment.
Who is the study for?
This trial is for children aged 3-21 with recurrent or progressive high-grade brain tumors who can swallow pills. They must have measurable disease, be recovered from prior treatments, and have stable health conditions. Those with controlled seizures or neurological deficits may qualify. Patients on birth control and HIV-positive individuals under certain criteria are also eligible.Check my eligibility
What is being tested?
The trial tests INCB7839 in children with high-grade gliomas that came back or got worse after initial treatment. It's a phase 1 study to see how safe the drug is and how it affects these types of brain tumors.See study design
What are the potential side effects?
While specific side effects for INCB7839 aren't listed, common ones for cancer drugs include nausea, fatigue, blood count changes increasing infection risk, liver function issues, allergic reactions, and potential bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't taken any growth factor medications for over a week.
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I have tried at least one cancer treatment other than surgery and it didn't work.
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My neurological symptoms have not changed for at least a week.
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My brain tumor is aggressive and has come back or gotten worse.
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I am between 3 and 21 years old.
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My dose of dexamethasone has been stable or decreasing for the last week.
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My body surface area fits within the required range for my medication dose.
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I am between 3 and 21 years old.
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I can do most activities but may need assistance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years following last dose of incb7839.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years following last dose of incb7839.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) and/or recommend Phase II dose (RP2D) of INCB7839.
To characterize the apparent oral clearance [CL/F] of INCB7839 administered on this schedule in children with recurrent/progressive high-grade glioma.
To characterize the area under the plasma concentration versus time curve (AUC) of INCB7839 administered on this schedule in children with recurrent/progressive high-grade glioma.
+3 moreSecondary outcome measures
To make a preliminary assessment of duration of response in children with recurrent/progressive high-grade glioma.
To make a preliminary assessment of overall survival in children with recurrent/progressive high-grade glioma.
To make a preliminary assessment of progression-free survival in children with recurrent/progressive high-grade glioma.
Other outcome measures
ADAM10 inhibition of HER2 extracellular domain in serum.
To assess and monitor ADAM10 inhibition of neuroligin-3 (NLGN3) in cerebral spinal fluid.
To characterize the maximum concentration [CMAX] of INCB7839 in cerebrospinal fluid.
Side effects data
From 2019 Phase 1 & 2 trial • 30 Patients • NCT0214145143%
Anorexia
43%
Platelet count decreased
29%
Pain
14%
Lymphocyte count decreased
14%
Akathisia
14%
Vomiting
14%
Pain of skin
14%
Neutrophil count decreased
14%
Generalized muscle weakness (hands)
14%
Myalgia
14%
Alanine aminotransferase increased
14%
Depression
14%
White blood cell decreased
14%
Ovarian Cancer
14%
External ear pain
14%
Dry Mouth
14%
Eye pain
14%
Pain in extremity
14%
Sinusitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
INCB7839 300 mg (Phase I)
INCB7839 300 mg (Phase II)
INCB7839 100 mg (Phase I)
INCB7839 200 mg (Phase I)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dose-findingExperimental Treatment1 Intervention
INCB7839 dosing will begin at 120 mg/m2/dose BID which is equivalent to the adult RP2D (200 mg PO BID) based on a typical adult size of 1.67m2. The INCB7839 dose may be decreased to 80 mg/m2/dose BID if the staring dose is not tolerable. 28 consecutive days (4 weeks) will constitute one course. Patients may continue to receive INCB7839 for 26 courses (approximately 2 years).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INCB7839
2014
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,654 Total Patients Enrolled
322 Trials studying Glioblastoma
23,102 Patients Enrolled for Glioblastoma
American Lebanese Syrian Associated Charities (ALSAC)UNKNOWN
8 Previous Clinical Trials
672 Total Patients Enrolled
4 Trials studying Glioblastoma
407 Patients Enrolled for Glioblastoma
Pediatric Brain Tumor ConsortiumLead Sponsor
37 Previous Clinical Trials
1,569 Total Patients Enrolled
8 Trials studying Glioblastoma
505 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any growth factor medications for over a week.I have tried at least one cancer treatment other than surgery and it didn't work.My brain tumor is aggressive and has come back or gotten worse.My neurological symptoms have not changed for at least a week.My close family has a history of blood clots.You are pregnant or breastfeeding.My organs and bone marrow are working well.You must wait a certain amount of time after your previous treatment before participating in the study.I have not had significant new brain bleeding shown on an MRI in the last 2 weeks.My diagnosis is one of the specified brain or spinal cord tumors.I have recovered from side effects of my previous cancer treatments.I have recovered from side effects of my previous cancer treatments.I have had blood clots not related to a central line.I am between 3 and 21 years old.My body surface area fits the required range for the dose.My dose of dexamethasone has been stable or decreasing for the last week.I do not have any other type of cancer.I have a known bleeding or clotting disorder.My body surface area fits within the required range for my medication dose.I can attend all follow-up visits and stick to the study plan.My cancer has spread widely or to the lining of my brain/spinal cord.My high blood pressure is not under control.You have a history of allergic reactions to similar drugs or pork products.I cannot receive blood clot prevention treatments.You should be able to swallow pills without crushing or breaking them.I am between 3 and 21 years old.I can do most activities but may need assistance.My seizures, if any, are well managed.I am not on any other cancer treatments or experimental drugs.I use birth control that contains estrogen.I have had bleeding in my brain from a tumor.You are able to swallow pills without crushing or breaking them.
Research Study Groups:
This trial has the following groups:- Group 1: Dose-finding
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial enrolling participants at present?
"Affirmative. As per the information hosted on clinicaltrials.gov, this trial is actively seeking participants and was first published on May 27th 2020. The study requires 28 individuals to be recruited from 13 different locations."
Answered by AI
In which locations can this research be accessed?
"This research is conducted at various sites including the Baylor College of Medicine in Houston, St. Jude Children Research Hospital in Memphis, and National Cancer Institute Pediatric Oncology Branch in Bethesda alongside 13 other medical centres."
Answered by AI
Who is qualified to participate in this investigation?
"This clinical trial is accepting 28 participants suffering from dipg who are 3-21 years of age. In order to be eligible, individuals must fulfill the following conditions: having a body surface area (BSA) ≥ 0.70-2.50 m2 for 120 mg/m2/dose BID or ≥ 0.55-2.80 m2 for 80 mg/m2/dose BID; presenting with one of several types of glioma, such as diffuse intrinsic pontine glioma (DIPG); not displaying leptomeningeal spread; recovering from any prior treatments like chemotherapy, immunotherapy"
Answered by AI
Has the FDA sanctioned INCB7839 for usage?
"As this trial is in its early stages, the safety of INCB7839 has been evaluated to be a 1. This indicates that there is limited clinical data corroborating both efficacy and patient safety at present."
Answered by AI
How many participants are being recruited for this clinical trial?
"28 willing and eligible participants are essential for the success of this investigation. These individuals can register from locations such as Baylor College of Medicine in Houston, Texas or St. Jude Children Research Hospital in Memphis, Tennessee."
Answered by AI
Are there additional investigations utilizing INCB7839?
"In 2020, Cincinnati Children Hospital Medical Center first explored INCB7839. To date there has been one completed trial and 1 currently ongoing study based primarily in Houston, Texas."
Answered by AI
Are older individuals being accepted into the clinical trial?
"The enrollment requirements stipulate that suitable candidates must lie between 3 and 21 years old. For those who are below 18, there are 153 research studies available while elderly individuals (aged 65+) can access 596 trials."
Answered by AI
Who else is applying?
What state do they live in?
South Dakota
How old are they?
< 18
What site did they apply to?
Dana Farber Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
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