Study Evaluating EKB-569 in Advanced Colorectal Cancer

Phase 2

Completed

• Conditions: Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

• Registration Number: NCT00072748
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2003-11-10
• Study First Submitted QC: 2003-11-12
• Study First Posted: 2003-11-13
• Primary Completion: 2004-10
• Study Completion: 2004-10
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-20
• Last Update Posted: 2009-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified