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NCT04079179 · ClinicalTrials.gov registry record · Phase 2
Cobimetinib in Refractory Langerhans Cell Histiocytosis (LCH), and Other Histiocytic Disorders
A Phase 2 study of Langerhans Cell Histiocytosis and Neuro-Degenerative Disease, sponsored by Carl Allen.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 12
- Study locations
NCT04079179 is a Phase 2 study of Langerhans Cell Histiocytosis and Neuro-Degenerative Disease that is actively recruiting participants, run by Carl Allen. The registered enrollment target is 90 participants, below the 1,128-participant average among 8 other Langerhans Cell Histiocytosis trials with a reported enrollment target (92% lower). The trial reports 12 study locations across 10 states.
The verdict
NCT04079179, a Phase 2 study of Langerhans Cell Histiocytosis and Neuro-Degenerative Disease, is actively recruiting participants, sponsored by Carl Allen.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 12
- Study locations
Study Summary
This is a research study of a drug called cobimetinib in children and adults diagnosed with Langerhans cell histiocytosis (LCH), and other histiocytic disorders that has returned or does not respond to treatment. Cobimetinib blocks activation of a protein called Mitogen-activated protein kinase (MEK) that is part of incorrect growth signals in histiocytosis cells. Four different groups of patients will be enrolled.
Conditions Studied
Interventions
- DRUG Cobimetinib
Study Locations (12)
California
- Children's Hospital of Orange County - Orange
- UCSF Benioff Children's Hospital - San Francisco
Texas
- Children's Medical Center- UTSW - Dallas
- Texas Children's Hospital - Houston
Arizona
- Phoenix Children's Hospital - Phoenix
Arkansas
- Arkansas Children's Hospital - Little Rock
District of Columbia
- Children's National Hospital - Washington D.C.
Maryland
- John Hopkins University School of Medicine - Baltimore
Massachusetts
- Dana Farber Cancer Institute, Boston Children's - Boston
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2021-04-19 |
| Est. Completion | 2029-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04079179
The ClinicalTrials.gov registry entry for NCT04079179 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,128-participant average among 8 other Langerhans Cell Histiocytosis trials with a reported enrollment target (92% lower). The listed sponsor is Carl Allen, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Langerhans Cell Histiocytosis appearing as the primary indexed condition, and to 1 intervention - of which Cobimetinib is the first listed.
NCT04079179 reports 12 study locations spanning 10 distinct geographic areas - top geographies include California, Texas, Arizona.
Frequently Asked Questions
What is clinical trial NCT04079179 about?
NCT04079179 is a clinical study titled "Cobimetinib in Refractory Langerhans Cell Histiocytosis (LCH), and Other Histiocytic Disorders". This is a research study of a drug called cobimetinib in children and adults diagnosed with Langerhans cell histiocytosis (LCH), and other histiocytic disorders that has returned or does not respond to treatment. Cobimetinib blocks activation of a protein called Mitogen-activated protein kinase (MEK...
What is the current status of trial NCT04079179?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2021-04-19. Estimated completion is 2029-12.
What conditions does trial NCT04079179 study?
This clinical trial studies the following conditions: Langerhans Cell Histiocytosis, Neuro-Degenerative Disease, Erdheim-Chester Disease, Rosai-Dorfman Disease, Histiocytic Sarcoma.
What interventions are being tested in trial NCT04079179?
The interventions under investigation include: Cobimetinib (DRUG).
Who is sponsoring clinical trial NCT04079179?
This trial is sponsored by Carl Allen, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04079179 being conducted?
This trial has 12 study locations across Arizona, Arkansas, California, District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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