NCT00072748

Study Evaluating EKB-569 in Advanced Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasms
• Colonic Neoplasms
• Rectal Neoplasms

Interventions

Type	Name	Description
DRUG	EKB-569

Timeline

• Primary completion: 2004-10-01
• Completion: 2004-10-01
• First posted: 2003-11-13
• Last updated: 2009-08-21