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A Study of ABT-751 in Patients With Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00073138
Recruitment Status : Completed
First Posted : November 18, 2003
Last Update Posted : November 29, 2007
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Brief Summary:
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 or disease Intervention/treatment Phase
Colorectal Cancer Drug: ABT-751 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of ABT-751 in Subjects With Refractory Colorectal Carcinoma
Study Start Date : August 2003
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00073138

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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
Northwestern University
Chicago, Illinois, United States, 60611-5933
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
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
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Study Director: Helen Eliopoulos, MD Abbott

Layout table for additonal information Identifier: NCT00073138     History of Changes
Other Study ID Numbers: M02-446
First Posted: November 18, 2003    Key Record Dates
Last Update Posted: November 29, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases