A Phase 2 Open-Label Study Evaluating the Efficacy and Safety of Telatinib in Combination With Chemotherapy as First-Line Therapy in Subjects With Advanced Gastric Cancer

NCT00952497 Phase 2 COMPLETED

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.

Details

Lead sponsor	ACT Biotech, Inc
Phase	Phase 2
Status	COMPLETED
Enrolment	48
Start date	2009-06
Completion	2012-01

Conditions

• Gastric Cancer

Interventions

• Cisplatin, Capecitabine, Telatinib

Primary outcomes

• 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. — 6 months

Countries

United States, Spain