A Study of ABT-751 in Patients With Colorectal Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

November 17, 2003

Last Updated Date

November 28, 2007

Start Date ^ICMJE

August 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Objective Response Rate in subjects with Recurrent Colorectal Cancer [ Time Frame: 1 year ]

Original Primary Outcome Measures ^ICMJE

Response Rate

Change History

Complete list of historical versions of study NCT00073138 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Time to Tumor Progression (TTP)
Survival
Toxicities associated with treatment administration

Descriptive Information

Brief Title ^ICMJE

A Study of ABT-751 in Patients With Colorectal Cancer

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Colorectal Cancer

Intervention ^ICMJE

Drug: ABT-751

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00073138

Responsible Party

Study ID Numbers ^ICMJE

M02-446

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Helen Eliopoulos, MD

Abbott

Information Provided By

Abbott

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP