Colorectal Neoplasms Clinical Trial
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
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