Trials / Unknown
UnknownNCT02213861
Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- TetraLogic Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHAPE | topical gel |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2016-10-01
- Completion
- 2016-10-01
- First posted
- 2014-08-12
- Last updated
- 2016-10-20
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02213861. Inclusion in this directory is not an endorsement.