Ignite Creation Date:
2024-05-06 @ 2:19 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04283669
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-11
First Post:
2020-02-22
Brief Title:
Phase 2 Clinical Trial of Crizotinib for Children and Adults with Neurofibromatosis Type 2 and Progressive Vestibular Schwannomas
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Open-label Phase 2 Clinical Trial of Crizotinib for Children and Adults with Neurofibromatosis Type 2 and Progressive Vestibular Schwannomas
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
NF110
Brief Summary:
Subjects with Neurofibromatosis Type 2 NF2 and progressive vestibular schwannoma VS will be treated with crizotinib administered orally Crizotinib will be taken continuously until disease progression or unacceptable toxicity in continuous treatment cycles of 28 days each for a maximum of 12 cycles
Detailed Description:
Subjects with Neurofibromatosis Type 2 NF2 and progressive vestibular schwannoma VS will be treated with crizotinib administered orally Crizotinib will be taken continuously until disease progression or unacceptable toxicity in continuous treatment cycles of 28 days each for a maximum of 12 cycles Clinical response will be assessed by MRI volumetrics primary objective and audiology at the end of every 3rd cycle Subjects with volumetric tumor progression will be taken off protocol Patients who complete 12 cycles of treatment without disease progression but within the following 24 weeks show subsequent disease progression defined as 20 increase in target tumor volume compared to off-treatment volume will be eligible for re-treatment on study for up to 48 additional weeks provided they still meet study eligibility criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| W81XWH-17-2-0037 | OTHER_GRANT | CDMRP of the Dept of Defense US Army | None |