A Study of ABT-751 in Patients With Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00073138
• Other study ID #: M02-446
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2003
• Last updated: November 28, 2007
• Start date: August 2003
• Est. completion date: February 2005

Study information

• Verified date: November 2007
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• ABT-751

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Southern California	Los Angeles	California
United States	University of Wisconsin Medical Center	Madison	Wisconsin
United States	Cancer Institute Medical Group	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate in subjects with Recurrent Colorectal Cancer		1 year
Secondary	Time to Tumor Progression (TTP)		1 year
Secondary	Survival		2 years
Secondary	Toxicities associated with treatment administration		1 year