A Study of ABT-751 in Patients With Colorectal Cancer

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: 40
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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

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	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abbott

Study record dates

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: November 17, 2003
• First Posted (Estimate): November 18, 2003

Study Record Updates

• Last Update Posted (Estimate): November 29, 2007
• Last Update Submitted That Met QC Criteria: November 28, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: M02-446