A Study of ABT-751 in Patients With Colorectal Cancer

November 28, 2007 updated by: Abbott

A Phase 2 Study of ABT-751 in Subjects With Refractory Colorectal Carcinoma

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.

Study Overview

Status

Completed

Conditions

Colorectal Cancer

Intervention / Treatment

Drug: ABT-751

Study Type

Interventional

Enrollment

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate in subjects with Recurrent Colorectal Cancer Time Frame: 1 year	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Study Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

November 17, 2003

First Submitted That Met QC Criteria