Everolimus for Treatment of Disfiguring Cutaneous Lesions in Neurofibromatosis1 CRAD001CUS232T
NCT02332902 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2023-12-20
Summary
This trial is evaluating the use of oral Everolimus to determine if there is a reduction in the size of the disfiguring cutaneous lesions in patients with Neurofibromatosis 1 over a 6 month period. The evaluation will be done by 3D photography measuring volume with the LIFEVIZ Micro system.
Conditions
- Neurofibromatosis 1
Interventions
- DRUG
-
Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2 week intervals to attain a trough concentration of 5-15 ng/ml
Sponsors & Collaborators
-
Texas Neurofibromatosis Foundation
collaborator UNKNOWN -
The University of Texas Health Science Center, Houston
lead OTHER
Principal Investigators
-
Mary Kay Koenig, MD · The University of Texas Health Science Center, Houston
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-02-28
- Primary Completion
- 2016-03-31
- Completion
- 2016-03-31
Countries
- United States
Study Locations
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