Study Evaluating EKB-569 in Advanced Colorectal Cancer
Status:
Completed
Trial end date:
2004-10-01
Target enrollment:
Participant gender:
Summary
This non-randomized, open-label, outpatient clinical trial is designed to assess the safety
and efficacy of daily orally administered EKB-569 in subjects with advanced colorectal
cancer. Patients must have been previously treated with a fluoropyrimidine (5-FU or
capecitabine) and either oxaliplatin or irinotecan (given concurrently or as separate
regimens).
The primary objective of the study is to assess the clinical activity of EKB-569 administered
orally as a second-line or later stage treatment in subjects with advanced colorectal cancer.
Secondary objectives include:
- To further evaluate the safety of EKB-569
- To explore additional clinical activity parameters
- To explore subject survival
- To evaluate the pharmacokinetics of EKB-569
- To assess subject reported outcomes
EKB-569 will be administered orally as a single-agent. Eligible subjects will take EKB-569
daily as long as they do not have progressive disease and are tolerating treatment.