Ignite Creation Date:
2024-05-06 @ 3:37 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02332902
Status:
COMPLETED
Last Update Posted:
2023-12-20
First Post:
2014-12-12
Brief Title:
Everolimus for Treatment of Disfiguring Cutaneous Lesions in Neurofibromatosis1 CRAD001CUS232T
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Everolimus for Treatment of Disfiguring Cutaneous Lesions in Neurofibromatosis1- CRAD001CUS232T
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DCLNF1
Brief 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
Detailed Description:
Qualifying subjects will have a diagnosis of Neurofibromatosis 1 and have disfiguring cutaneous lesions that can be measured by photography The subjects will have photographs of the target lesionsbiopsies of the lesionsand safety blood laboratory tests at 3 time points baseline 3 months and 6 months which is end of treatment Everolimus will be taken orally for 6 months Subjects will visit the clinic monthly for an exam and adverse event evaluation Laboratory testing will be done at these visits if determined necessary by the PI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None