Ignite Creation Date:
2024-05-06 @ 3:45 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02367690
Status:
WITHDRAWN
Last Update Posted:
2023-01-20
First Post:
2015-02-09
Brief Title:
Study of Safety Tolerability and Pharmacokinetics of Topical Selinexor KPT-330 Diabetic Foot Ulcer DFU Patients
Sponsor:
Karyopharm Therapeutics Inc
Organization:
Karyopharm Therapeutics Inc
Study Overview
Official Title:
Phase 12 Multi-Dose Evaluator-Blinded Randomized Vehicle Standard Of Care-Controlled Dose-Escalation Study To Assess Safety Tolerability Pharmacokinetics Of Topical Selinexor In Patients With Diabetic Foot Ulcers
Status:
WITHDRAWN
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to enrollment challenges improved SOC during run-in phase no patients received KPT-330 Withdrawal is not a consequence of any safety concern
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with eligible diabetic foot ulcers will be screened treated and followed for complete ulcer closure This is a randomized trial All patients will receive standard-of-care treatment Additionally some patients will receive treatment with topical Selinexor gel and some will receive topical placebo gel
Detailed Description:
Approximately 30 patients who meet the eligibility criteria will be enrolled Eligible patients with diabetic foot ulcers will be screened randomized treated and followed for complete ulcer closure
After screening qualified patients will be treated for up to 12 weeks Patients who achieve complete ulcer closure will be followed for an additional 12 weeks
All patients will receive standard-of-care treatment After randomization some patients will be treated with topical Selinexor gel twice weekly and some patients will be treated with a topical placebo gel twice weekly Patients receiving Selinexor will be assigned to a sequential treatment cohort either a 10 μM μmolL 30 μM or 70 μM dose
After screening qualified patients will be treated for up to 12 weeks Patients who achieve complete ulcer closure will be followed for an additional 12 weeks
All patients will receive standard-of-care treatment After randomization some patients will be treated with topical Selinexor gel twice weekly and some patients will be treated with a topical placebo gel twice weekly Patients receiving Selinexor will be assigned to a sequential treatment cohort either a 10 μM μmolL 30 μM or 70 μM dose
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