A Study of ABT-751 in Patients With Colorectal Cancer

This study has been completed.

First Received on November 17, 2003. Last Updated on November 28, 2007 History of Changes

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00073138

Purpose

The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with colorectal cancer. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.

Condition	Intervention	Phase
Colorectal Cancer	Drug: ABT-751	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 2 Study of ABT-751 in Subjects With Refractory Colorectal Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: E 7010 ABT 751

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Objective Response Rate in subjects with Recurrent Colorectal Cancer [ Time Frame: 1 year ]

Secondary Outcome Measures:

Time to Tumor Progression (TTP) [ Time Frame: 1 year ]
Survival [ Time Frame: 2 years ]
Toxicities associated with treatment administration [ Time Frame: 1 year ]

Estimated Enrollment:	40
Study Start Date:	August 2003
Study Completion Date:	February 2005

Eligibility

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

Criteria

Inclusion Criteria

Colorectal cancer.
Recurrent tumor following treatment with irinotecan and/or oxaliplatin.
Able to tolerate normal activities of daily living.
Adequate bone marrow, kidney, and liver function.

Exclusion Criteria

Pregnant or breast feeding.
Anti-tumor therapy within 4 weeks of the start of ABT-751 administration.
Prior radiation therapy.
CNS metastasis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073138

Locations

United States, California
University of Southern California
Los Angeles, California, United States, 90089
Cancer Institute Medical Group
Santa Monica, California, United States, 90095-3961
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Northwestern University
Chicago, Illinois, United States, 60611-5933
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Wisconsin
University of Wisconsin Medical Center
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Helen Eliopoulos, MD

Abbott

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00073138 History of Changes
Other Study ID Numbers:	M02-446
Study First Received:	November 17, 2003
Last Updated:	November 28, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms

Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on February 12, 2012