22
Participants
Start Date
March 31, 2010
Primary Completion Date
April 30, 2012
Study Completion Date
July 31, 2012
Pralatrexate Injection
"Intravenous (IV) push administration over 3-5 minutes.~Initial dose: 190 mg/m2~Dose reductions per protocol: 150 mg/m2, 120 mg/m2, and 100 mg/m2 allowed for defined toxicities.~Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met."
Vitamin B12
"1 mg intramuscular injection~Administered within 10 weeks prior to first dose of pralatrexate, every 8-10 weeks throughout the study and for at least 30 days after the last dose of pralatrexate."
Folic Acid
"1.0-1.25 mg orally~Administered daily for at least 7 days prior to first dose of pralatrexate, throughout the study and for at least 30 days after the last dose of pralatrexate."
University of Debrecen Medical and Health Science Center, Debrecen
Institut Paoli Calmettes, Marseille
Centre Georges François Leclerc, Dijon
Centre Lutte Contre le Cancer Val d'Aurelle (CRLC), Montpellier
The West Clinic, Memphis
Institut Jean-Godinot, Reims
Centre Régional de Lutte Contre le Cancer Alexis Vautrin, Vandœuvre-lès-Nancy
Centre Léon Bérard, Lyon
Providence Cancer Center, Portland
Fakultní nemocnice Olomouc, Olomouc
Multiscan, s.r.o., Pardubice
Fakultní nemocnice Královské Vinohrady - FNKV, Prague
Semmelweis University Budapest, Budapest
National Health Centre of Hungary, Budapest
Lead Sponsor
Acrotech Biopharma Inc.
INDUSTRY