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

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

MedlinePlus related topics:

Cancer Colorectal Cancer

Drug Information available for:

EKB 569

U.S. FDA Resources

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

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

Study ID Numbers:	3095A1-200
First Received:	November 10, 2003
Last Updated:	May 18, 2006
ClinicalTrials.gov Identifier:	NCT00072748
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Advanced Colorectal Cancer

Colorectal Carcinoma

Colorectal Tumors

Neoplasms, Colorectal

Study placed in the following topic categories:

Digestive System Neoplasms

Rectal Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Intestinal Neoplasms

Carcinoma

Rectal neoplasm

Digestive System Diseases

Gastrointestinal Neoplasms

Colonic Neoplasms

Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on November 30, 2008

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