Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553365
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-03
Brief Title:
Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open Single-Arm Phase II Study Evaluating the Efficacy and Safety of FCN-159 in Selected NF2-associated Nerve Sheath Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the efficacy and safety of FCN-159 in patients with specific NF2-associated nerve sheath tumors
Detailed Description:
1 A phase 2 single arm single center study total 30 patients will be enrolled
2 To evaluate the safety and efficacy of FCN-159 a Mek inhibitor to treat NF2 associated nerve sheath tumors age16 including benign and malignant tumors
3 Primary endpoint Objective response rate ORRSecondary Outcome Measures Clinical benefit rate CBR24w WRS OS et al
2 To evaluate the safety and efficacy of FCN-159 a Mek inhibitor to treat NF2 associated nerve sheath tumors age16 including benign and malignant tumors
3 Primary endpoint Objective response rate ORRSecondary Outcome Measures Clinical benefit rate CBR24w WRS OS et al
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