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INCB7839 in Treating Children With Recurrent/Progressive High-Grade Gliomas

NCT04295759 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-01-05

Study results available
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Summary

This is a multicenter phase 1 trial of INCB7839 for children with recurrent or progressive high-grade gliomas, including, but not limited to, diffuse intrinsic pontine glioma (DIPG) and other diffuse midline gliomas (DMGs), after upfront therapy.

Conditions

  • Glioblastoma Multiforme
  • Anaplastic Astrocytoma
  • Anaplastic Oligodendroglioma
  • DIPG
  • High-grade Astrocytoma NOS
  • CNS Primary Tumor, NOS (Malignant Glioma)

Interventions

DRUG

INCB7839

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).

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • American Lebanese Syrian Associated Charities

    collaborator OTHER

  • Pediatric Brain Tumor Consortium

    lead NETWORK

Principal Investigators

  • Michelle Monje, MD, PhD · Stanford University and Lucile Packard Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2023-12-31
Completion
2024-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04295759 on ClinicalTrials.gov