Study Evaluating EKB-569 in Advanced Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00072748|
Recruitment Status : Completed
First Posted : November 13, 2003
Last Update Posted : August 21, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms Colonic Neoplasms Rectal Neoplasms||Drug: EKB-569||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Masking:||None (Open Label)|
|Actual Primary Completion Date :||October 2004|
|Actual Study Completion Date :||October 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072748
|Study Director:||Medical Monitor, MD||Wyeth is now a wholly owned subsidiary of Pfizer|