48
Participants
Start Date
June 30, 2009
Primary Completion Date
October 31, 2011
Study Completion Date
January 31, 2012
Cisplatin, Capecitabine, Telatinib
Subjects will receive: Chemotherapy (capecitabine and cisplatin) and telatinib Capecitabine will be administered (1000 mg/m2) twice daily for 14 days followed by a 7-day rest period. Cisplatin (80 mg/m2) will be given as a 1-3 hour infusion once every 3 weeks. Telatinib (3 tablets) will be administered orally, twice daily as a continuous administration. After a maximum of 6 cycles of cisplatin, subjects continue with capecitabine and telatinib or monotherapy with either study drug,depending on the toxicity experienced by the subject, until disease progression.
University of Pennsylvania, Abramson Cancer Center, Philadelphia
Hospital Universitario Ramon y Cajal, Madrid
Hospital Clinico San Carlos, Madrid
Hospital Universitario 12 de Octubre, Madrid
Central Georgia Cancer Care, P.C., Macon
The West Clinic, Memphis
Hospital Universitario Marques de Valdecilla, Santander
The University of Texas MD Anderson Cancer Center, Houston
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco
Hospital Vall d' Hebron, Barcelona
Hospital Universitari Germans Trias i Pujol, Barcelona
Lead Sponsor
ACT Biotech, Inc
INDUSTRY