Study Evaluating EKB-569 in Advanced Colorectal Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

November 10, 2003

Last Updated Date

August 20, 2009

Start Date ^ICMJE

Primary Completion Date

October 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00072748 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Study Evaluating EKB-569 in Advanced Colorectal Cancer

Official Title ^ICMJE

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Safety/Efficacy Study

Condition ^ICMJE

Colorectal Neoplasms
Colonic Neoplasms
Rectal Neoplasms

Intervention ^ICMJE

Drug: EKB-569

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2004

Primary Completion Date

October 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00072748

Responsible Party

Study ID Numbers ^ICMJE

3095A1-200

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor, MD

Wyeth

Information Provided By

Wyeth

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP