34
Participants
Start Date
March 31, 2010
Primary Completion Date
August 31, 2015
Study Completion Date
August 31, 2015
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."
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."
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)."
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)."
Memorial Sloan-Kettering Cancer Center, New York
University of Pittsburgh School of Medicine, Pittsburgh
Ospedale Sant'Orsola - Policlinico Sant'Orsola, Bologna
MD Anderson Cancer Center, Houston
Stanford University School of Medicine, Stanford
Lead Sponsor
Acrotech Biopharma Inc.
INDUSTRY