Back to resultsA Study of ABT-751 in Patients With Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ABT-751
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility 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.
Sites / Locations
- University of Southern California
- Cancer Institute Medical Group
- Northwestern University
- University of Chicago Medical Center
- Duke University Medical Center
- University of Wisconsin Medical Center
Outcomes
Primary Outcome Measures
Objective Response Rate in subjects with Recurrent Colorectal Cancer
Secondary Outcome Measures
Time to Tumor Progression (TTP)
Survival
Toxicities associated with treatment administration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00073138
Brief Title
A Study of ABT-751 in Patients With Colorectal Cancer
Official Title
A Phase 2 Study of ABT-751 in Subjects With Refractory Colorectal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ABT-751
Primary Outcome Measure Information:
Title
Objective Response Rate in subjects with Recurrent Colorectal Cancer
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time to Tumor Progression (TTP)
Time Frame
1 year
Title
Survival
Time Frame
2 years
Title
Toxicities associated with treatment administration
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Eliopoulos, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Facility Name
Cancer Institute Medical Group
City
Santa Monica
State/Province
California
ZIP/Postal Code
90095-3961
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-5933
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Wisconsin Medical Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
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A Study of ABT-751 in Patients With Colorectal Cancer
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