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Clinical Trial Summary

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.


Clinical Trial Description

This is a multi-center, dose-finding, Phase 1 study of pralatrexate plus bexarotene in patients who have relapsed or refractory CTCL.

Primary Objective(s):

• Determine the maximum tolerated dose (MTD) and recommended dose of pralatrexate plus bexarotene with concurrent vitamin B12 and folic acid supplementation when administered to patients who have failed prior systemic treatment.

Secondary Objective(s):

- Determine the safety profile of pralatrexate plus bexarotene when administered to patients with relapsed/refractory cutaneous T-cell lymphoma (CTCL).

- Collect preliminary efficacy data.

- Determine the pharmacokinetic (PK) profile of pralatrexate plus bexarotene in patients who underwent plasma PK sampling ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01134341
Study type Interventional
Source Acrotech Biopharma LLC
Contact
Status Completed
Phase Phase 1
Start date March 2010
Completion date August 2015

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