The objectives of this study are to evaluate the anti-tumor activity, safety, and tolerability of telatinib when used in combination with chemotherapy (capecitabine and cisplatin) as first-line therapy in subjects with advanced gastric cancer. The primary objective is to assess progression free survival (PFS) in subjects receiving telatinib in combination with chemotherapy (capecitabine and cisplatin). The secondary objectives are to assess overall survival, overall response rate, safety and tolerability, pharmacokinetics and biomarkers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
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.
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Central Georgia Cancer Care, P.C.
Macon, Georgia, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States
The primary objective is to assess progression free survival (PFS). PFS will be measured from the date of first study drug administration to the date of first scan that first documents disease progression.
Time frame: 6 months
Other efficacy variables are overall survival, overall response rate, safety and tolerability. Exploratory analyses may be performed to investigate the correlation of biomarker status with treatment effect and response.
Time frame: 18 months from start of enrollment to evaluation of primary endpoint
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The West Clinic
Memphis, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Hospital Vall d' Hebron
Barcelona, Spain
Hospital Universitari Germans Trias i Pujol
Barcelona, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
...and 1 more locations