- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00072748
Study Evaluating EKB-569 in Advanced Colorectal Cancer
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed and dated, institutional review board (IRB) or independent ethics committee (IEC)-approved informed consent form before any protocol-specific screening procedures
- Previous histologic diagnosis of adenocarcinoma of the colon or rectum
- EGFR expression by immunohistochemical analysis (must be > or = 20% positive tumor cells in prior tumor biopsy specimens)
Exclusion Criteria:
- Chemotherapy, radiotherapy, anticancer immunotherapy, or investigational agents within 4 weeks of treatment day 1 (6 weeks if the previous regimen included mitomycin or nitrosoureas).
- Prior epidermal growth factor receptor-targeting therapy
- Known central nervous system (CNS) metastases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Masking: None (Open Label)
Collaborators and Investigators
Study record dates
Study Major Dates
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplasms
- Colorectal Neoplasms
- Rectal Neoplasms
- Colonic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- EKB 569
Other Study ID Numbers
- 3095A1-200
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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