drugset / Trial / NCT01433731
Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)
Phase 1
Completed
18 enrolled
TetraLogic Pharmaceuticals
PPD Development, LP · collabThe Leukemia and Lymphoma Society · collabTherapeutics, Inc. · collabVeristat, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to investigate the safety and tolerability of topical SHP141 applied directly to skin lesions in patients with Stage IA, IB, or IIA Cutaneous T-cell Lymphoma. This study will also investigate the effect of SHP141 on skin lesions in patients with Stage IA, IB, or IIA CTCL.
Timeline
- Start
- 2011-11
- Primary completion
- 2013-09
- Completion
- 2013-09
Outcome
Met primary endpoint
release “Remetinostat phase II data demonstrating efficacy on skin lesions, reduction of itching and high tolerability in patients with early-stage MF-type CTCL were announced.” medivir.com ↗
release “In the phase II study, remetinostat also demonstrated a dose-dependent efficacy on skin lesions, as measured by the primary end-point CAILs.” medivir.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Remetinostat | Small molecule | 0.1 % | Topical |
| Subject | Remetinostat | Small molecule | 0.5 % | Topical |
| Subject | Remetinostat | Small molecule | 1 % | Topical |