NCT01134341

Pralatrexate and Bexarotene in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma

A Phase 1, Open-label, Dose-finding Study of Pralatrexate Plus Systemic Bexarotene in Patients With Relapsed or Refractory Cutaneous T Cell Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Acrotech Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Cutaneous T-cell Lymphoma
• Mycosis Fungoides
• Sezary Syndrome
• Primary Cutaneous Anaplastic Large Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Pralatrexate Injection	Intravenous (IV) push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride). 10 or 15 mg/m2, depending on cohort assignment. Dose reductions allowed for protocol-specified criteria. Administered weekly for 3 weeks of 4-week cycle (weekly for 3 weeks with one week of rest) until criteria for discontinuation per the protocol are met.
DRUG	Bexarotene Capsules	150 or 300 mg orally, depending on cohort assignment. Provided as 75 mg capsules and taken with a meal. Dose reductions allowed for protocol-specified criteria and implemented per the Targretin® package insert. Administered daily until criteria for study treatment discontinuation per the protocol are met.
DIETARY_SUPPLEMENT	Vitamin B12	1 mg intramuscular injection Administered within 10 weeks prior to start of study treatment, every 8-10 weeks throughout the study and for 30 days after last study treatment (dose of pralatrexate or bexarotene).
DIETARY_SUPPLEMENT	Folic Acid	1-1.25 mg orally Administered daily for at least 7 days prior to start of study treatment, throughout the study and for 30 days after last study treatment (dose of pralatrexate or bexarotene).

Timeline

• Start date: 2010-03-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2010-06-02
• Last updated: 2019-12-18

Locations

5 sites across 2 countries: United States, Italy