119
Participants
Start Date
May 31, 2007
Primary Completion Date
May 31, 2011
Study Completion Date
August 31, 2011
Pralatrexate Injection
"Intravenous (IV) push administration over 30 seconds to 5 minutes into a patent IV line containing normal saline (0.9% sodium chloride).~Sequential Dosing: 10 mg/m2 every 2 weeks (days 1 and 15) of a 4-week cycle until criteria for discontinuation per the protocol are met.~Same Day Dosing: 15 mg/m2 every 2 weeks (days 1 and 15) of a 4-week cycle until criteria for discontinuation per the protocol are met."
Gemcitabine Hydrochloride
"Gemcitabine will be prepared and administered as an IV infusion as per manufacturer instructions.~Sequential Dosing: 400 mg/m2 every 2 weeks (days 2 and 16) of a 4-week cycle until criteria for discontinuation per the protocol are met.~Same Day Dosing: 600 mg/m2 every 2 weeks (days 1 and 15) of a 4-week cycle until criteria for discontinuation per the protocol are met."
Vitamin B12
"1 mg intramuscular injection~Administered within 10 weeks of enrollment, every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate."
Folic Acid
"1 mg orally~Administered daily for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days after last dose of pralatrexate."
New York University Hospital, New York
Memorial Sloan-Kettering Cancer Center, New York
Fox Chase Cancer Center, Philadelphia
Medical University of South Carolina, Charleston
University of Chicago Hospital, Chicago
Washington University School of Medicine, St Louis
University of Nebraska Medical Center, Omaha
UT MD Anderson Cancer Center, Houston
Rocky Mountain Cancer Center, Denver
Stanford University School of Medicine, Stanford
Fred Hutchinson Cancer Research Center, Seattle
University of California at Los Angeles, Los Angeles
Dana-Farber Cancer Institute, Boston
The Cancer Center at Hackensack University Medical Center, Hackensack
Cancer Therapy & Research Center, San Antonio
Lead Sponsor
Acrotech Biopharma Inc.
INDUSTRY