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A Phase 1, Open-label, Dose-finding Study of Pralatrexate Plus Systemic Bexarotene in Patients With Relapsed or Refractory Cutaneous T Cell Lymphoma
This study is designed to determine the recommended dose, safety, pharmacokinetics, and early efficacy of the combination of pralatrexate plus oral bexarotene in patients with relapsed or refractory CTCL.
Details
| Lead sponsor | Acrotech Biopharma Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 34 |
| Start date | 2010-03 |
| Completion | 2015-08 |
Conditions
- Cutaneous T-cell Lymphoma
- Mycosis Fungoides
- Sezary Syndrome
- Primary Cutaneous Anaplastic Large Cell Lymphoma
Interventions
- Pralatrexate Injection
- Bexarotene Capsules
- Vitamin B12
- Folic Acid
Primary outcomes
- Dose Limiting Toxicity (DLT) Rate — Assessed weekly through cycle 1 (weeks 1-4)
DLT rate is the number of patients experiencing a DLT divided by number of evaluable patients and it will be summarized by dose level.
Countries
United States, Italy