Study Evaluating EKB-569 in Advanced Colorectal Cancer

Colorectal Neoplasms Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00072748
• Other study ID #: 3095A1-200
• Status: Completed
• Phase: Phase 2
• First received: November 10, 2003
• Last updated: August 20, 2009
• Est. completion date: October 2004

Study information

• Verified date: August 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Neoplasms
• Neoplasms
• Rectal Neoplasms

Intervention

Drug:
• EKB-569

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer