Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-01-03 @ 9:02 PM
Study NCT ID:
NCT02213861
Status:
UNKNOWN
Last Update Posted:
2016-10-20
First Post:
2014-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma
Sponsor:
TetraLogic Pharmaceuticals
Organization:
Study Overview
Official Title:
A Randomized Phase 2 Study to Evaluate Three Treatment Regimens of SHAPE, a Histone Deacetylase Inhibitor, in Patients With Stage IA, IB or IIA Cutaneous T-Cell Lymphoma
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of SHAPE administered topically to skin lesions in patients with early-stage cutaneous T-cell lymphoma (CTCL).
Detailed Description:
This is a Phase 2, multicenter, open-label, randomized study to evaluate the efficacy and safety of SHAPE Gelled Solution applied topically daily or twice daily for 26 consecutive weeks to specified skin lesions in patients with Stage IA, IB or IIA CTCL. Patients responding to treatment will be allowed to continue on study for a maximum of 52 weeks.
Study Oversight
Has Oversight DMC:
False
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?: