Study Evaluating EKB-569 in Advanced Colorectal Cancer - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00072748

Purpose

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.

Condition	Intervention	Phase
Colorectal Neoplasms Colonic Neoplasms Rectal Neoplasms	Drug: EKB-569	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: EKB 569

U.S. FDA Resources

Further study details as provided by Wyeth:

Enrollment:	63
Study Completion Date:	October 2004
Primary Completion Date:	October 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072748

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided

Study ID Numbers:	3095A1-200
Study First Received:	November 10, 2003
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00072748 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Advanced Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumors
Neoplasms, Colorectal

Additional relevant MeSH terms:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms

Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 09, 2009