Status:
COMPLETED
Study Evaluating EKB-569 in Advanced Colorectal Cancer
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Colorectal Neoplasms
Colonic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00072748
End Date
October 1 2004
Last Update
August 21 2009
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