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| Sponsor: | Wyeth |
|---|---|
| Information provided by: | Wyeth |
| ClinicalTrials.gov Identifier: | NCT00072748 |
Purpose
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:
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 | Intervention | Phase |
|---|---|---|
|
Colorectal Neoplasms Colonic Neoplasms Rectal Neoplasms |
Drug: EKB-569 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Safety/Efficacy Study |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | 3095A1-200 |
| Study First Received: | November 10, 2003 |
| Last Updated: | August 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00072748 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Advanced Colorectal Cancer Colorectal Carcinoma Colorectal Tumors Neoplasms, Colorectal |
|
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Neoplasms Colonic Neoplasms Colorectal Neoplasms |