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NCT03389802 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of APX005M in Pediatric Central Nervous System Tumors
A Phase 1 study of Glioblastoma Multiforme and Medulloblastoma, sponsored by Pediatric Brain Tumor Consortium.
- Active
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 11
- Study locations
NCT03389802 is a Phase 1 study of Glioblastoma Multiforme and Medulloblastoma that is active but no longer recruiting, run by Pediatric Brain Tumor Consortium. The registered enrollment target is 32 participants, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (67% lower). The trial reports 11 study locations across 10 states.
The verdict
NCT03389802, a Phase 1 study of Glioblastoma Multiforme and Medulloblastoma, is active but no longer recruiting, sponsored by Pediatric Brain Tumor Consortium.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 11
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of APX005M in treating younger patients with primary malignant central nervous system tumor that is growing, spreading, or getting worse (progressive), or newly diagnosed diffuse intrinsic pontine glioma. APX005M can trigger activation of B cells, monocytes, and dendritic cells and stimulate cytokine release from lymphocytes and monocytes. APX005M can mediate a direct cytotoxic effect on CD40+ tumor cells.
Conditions Studied
Interventions
- BIOLOGICAL APX005M treatment for recurrent or refractory primary malignant CNS tumor patients
- BIOLOGICAL APX005M treatment for newly diagnosed DIPG patients
Study Locations (11)
California
- Children's Hospital Los Angeles - Los Angeles
- Lucile Packard Children Hospital Stanford University - Palo Alto
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Childrens National Medical Center - Washington D.C.
Georgia
- Children's Healthcare of Atlanta - Atlanta
Illinois
- Lurie Childrens Hospital-Chicago - Chicago
New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- Cincinnati Children Hospital Medical Center - Cincinnati
Pennsylvania
- Children Hospital of Pittsburgh of UPMC - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03389802
The ClinicalTrials.gov registry entry for NCT03389802 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (67% lower). The listed sponsor is Pediatric Brain Tumor Consortium, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 2 interventions - of which APX005M treatment for recurrent or refractory primary malignant CNS tumor patients is the first listed.
NCT03389802 reports 11 study locations spanning 10 distinct geographic areas - top geographies include California, Colorado, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT03389802 about?
NCT03389802 is a clinical study titled "Phase I Study of APX005M in Pediatric Central Nervous System Tumors". This phase I trial studies the side effects and best dose of APX005M in treating younger patients with primary malignant central nervous system tumor that is growing, spreading, or getting worse (progressive), or newly diagnosed diffuse intrinsic pontine glioma. APX005M can trigger activation of B c...
What is the current status of trial NCT03389802?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2018-03-01. Estimated completion is 2026-06-30.
What conditions does trial NCT03389802 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Medulloblastoma, Diffuse Intrinsic Pontine Gliomas (DIPG), High-grade Astrocytoma Not Otherwise Specified (NOS), CNS Primary Tumor, Not Otherwise Specified (NOS).
What interventions are being tested in trial NCT03389802?
The interventions under investigation include: APX005M treatment for recurrent or refractory primary malignant CNS tumor patients (BIOLOGICAL), APX005M treatment for newly diagnosed DIPG patients (BIOLOGICAL).
Who is sponsoring clinical trial NCT03389802?
This trial is sponsored by Pediatric Brain Tumor Consortium, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03389802 being conducted?
This trial has 11 study locations across California, Colorado, District of Columbia, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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