30
Participants
Start Date
July 31, 2008
Primary Completion Date
April 30, 2011
Study Completion Date
September 30, 2011
Pralatrexate Injection
"Intravenous (IV) push administration over 3-5 minutes via a peripheral IV line containing normal saline (0.9% sodium chloride).~Initial dose: 190 mg/m2~Dose reductions per protocol: 150 mg/m2, 120 mg/m2 and 100 mg/m2 will be allowed for defined toxicity.~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 of enrollment, every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate."
Folic Acid
"1-1.25 mg orally~Administered daily for at least 7 days prior to enrollment, throughout the study and for at least 30 days after last dose of pralatrexate."
Institut Jules Bordet, Brussels
Centro de Terapia Radiante Cumbres (CAICI), Rosario
Algemeen Ziekenhuis Middelheim, Antwerp
Hospital Del Mar - Barcelona, Barcelona
CHU Zagreb University Hospital Center Rebro in Zagreb, Zagreb
"Clinic of Oncology and Nuclear Medicine, CH Sestre Milosrdnice", Zagreb
University of Rochester Cancer Center, Rochester
CH Split Clinic of Oncology and Radiotherapy, Split
Peachtree Hematology/Oncology Consultants, Atlanta
Hospital Virgen del Rocio, Seville
Centre Oscar Lambret, Lille
Institut Sainte Catherine, Avignon
University of Utah, Huntsman Cancer Institute, Salt Lake City
The University of Arizona Health Sciences Center, Tucson
Centre Hospitalier Rene Dubos, Pontoise
IONC (Instituto Oncológuci de Cordoba), Córdoba
Hopital Foch, Suresnes
Institut Gustave Roussy, Villejuif
Ciutat Sanitari de Vall d'Hebron, Barcelona
Lead Sponsor
Acrotech Biopharma Inc.
INDUSTRY