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NCT02101736 · ClinicalTrials.gov registry record · Phase 2
Cabozantinib for Plexiform Neurofibromas (PN) in Subjects With NF1 in Children and Adults
A Phase 2 study of NF1 and Neurofibromatosis, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 12
- Study locations
NCT02101736 is a Phase 2 study of NF1 and Neurofibromatosis that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 45 participants, below the 73-participant average among 6 other NF1 trials with a reported enrollment target (38% lower). The trial reports 12 study locations across 11 states.
The verdict
NCT02101736, a Phase 2 study of NF1 and Neurofibromatosis, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 12
- Study locations
Study Summary
This study, "A Phase II Study of Cabozantinib (XL l84) for Plexiform Neurofibromas in Subjects with Neurofibromatosis Type I in Children and Adults diagnosed with Neurofibromatosis Type 1 (NF1) and have a type of tumor called a plexiform neurofibroma (PN). Neurofibromas are tumors that develop from the cells and tissues that cover the nerves. Plexiform neurofibromas can be disfiguring, painful, and life-threatening. These types of tumors typically do not respond well to most treatment approaches such as chemotherapy, radiation, and surgery because of their slow growth and location near vital structures of the body such as nerves, blood vessels, and the airway. The primary objective is to determine the response rate of NF1 patients with plexiform neurofibromas treated with Cabozantinib therapy using MRI scans. The objective response rate to cabozantinib is defined as ≥ 20% reduction in tumor volume at the end of 12 cycles.
Conditions Studied
Interventions
- DRUG Cabozantinib
Study Locations (12)
Illinois
- Lurie Children's Hospital of Chicago - Chicago
- University of Chicago - Chicago
California
- Children's Hospital Los Angeles - Los Angeles
District of Columbia
- Children's National Medical Center - Washington D.C.
Indiana
- Indiana Unversity - Indianapolis
Maryland
- National Cancer Institute (NCI) - Bethesda
Massachusetts
- Children' Hospital Boston and Massachusetts General Hospital - Boston
Missouri
- Washington University - St. Louis - St Louis
New York
- New York University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2014-06 |
| Est. Completion | 2022-02-16 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02101736
The ClinicalTrials.gov registry entry for NCT02101736 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 73-participant average among 6 other NF1 trials with a reported enrollment target (38% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with NF1 appearing as the primary indexed condition, and to 1 intervention - of which Cabozantinib is the first listed.
NCT02101736 reports 12 study locations spanning 11 distinct geographic areas - top geographies include Illinois, California, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT02101736 about?
NCT02101736 is a clinical study titled "Cabozantinib for Plexiform Neurofibromas (PN) in Subjects With NF1 in Children and Adults". This study, "A Phase II Study of Cabozantinib (XL l84) for Plexiform Neurofibromas in Subjects with Neurofibromatosis Type I in Children and Adults diagnosed with Neurofibromatosis Type 1 (NF1) and have a type of tumor called a plexiform neurofibroma (PN). Neurofibromas are tumors that develop from ...
What is the current status of trial NCT02101736?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2014-06. Estimated completion is 2022-02-16.
What conditions does trial NCT02101736 study?
This clinical trial studies the following conditions: NF1, Neurofibromatosis, Plexiform Neurofibromas.
What interventions are being tested in trial NCT02101736?
The interventions under investigation include: Cabozantinib (DRUG).
Who is sponsoring clinical trial NCT02101736?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02101736 being conducted?
This trial has 12 study locations across California, District of Columbia, Illinois, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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