A Study of ABT-751 in Patients With Colorectal Cancer

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00073138
• Collaborator: (none)
• Enrollment: 40
• Locations: 6
• Duration (Months): 18.1
• Patients Per Site: 6.7
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: ABT-751	Phase 2

Study Design

• Study Type: Interventional
• 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: Aug 1, 2003
• Actual Study Completion Date: Feb 1, 2005

Outcome Measures

Primary Outcome Measures

1. Objective Response Rate in subjects with Recurrent Colorectal Cancer [1 year]

Secondary Outcome Measures

1. Time to Tumor Progression (TTP) [1 year]

2. Survival [2 years]

3. Toxicities associated with treatment administration [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California	Los Angeles	California	United States	90089
2	Cancer Institute Medical Group	Santa Monica	California	United States	90095-3961
3	Northwestern University	Chicago	Illinois	United States	60611-5933
4	University of Chicago Medical Center	Chicago	Illinois	United States	60637
5	Duke University Medical Center	Durham	North Carolina	United States	27710
6	University of Wisconsin Medical Center	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• Abbott

Investigators

• Study Director: Helen Eliopoulos, MD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00073138
• Other Study ID Numbers: M02-446
• First Posted: Nov 18, 2003
• Last Update Posted: Nov 29, 2007
• Last Verified: Nov 1, 2007

• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Nov 29, 2007