NCT00073138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 colorectal-cancer

Timeline
Completed

Started Aug 2003

Shorter than P25 for phase_2 colorectal-cancer

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
Last Updated

November 29, 2007

Status Verified

November 1, 2007

First QC Date

November 17, 2003

Last Update Submit

November 28, 2007

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate in subjects with Recurrent Colorectal Cancer

    1 year

Secondary Outcomes (3)

  • Time to Tumor Progression (TTP)

    1 year

  • Survival

    2 years

  • Toxicities associated with treatment administration

    1 year

Interventions

ABT-751DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant or breast feeding.
  • Anti-tumor therapy within 4 weeks of the start of ABT-751 administration.
  • Prior radiation therapy.
  • CNS metastasis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Southern California

Los Angeles, California, 90089, United States

Location

Cancer Institute Medical Group

Santa Monica, California, 90095-3961, United States

Location

Northwestern University

Chicago, Illinois, 60611-5933, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Wisconsin Medical Center

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

ABT751

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Helen Eliopoulos, MD

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 17, 2003

First Posted

November 18, 2003

Study Start

August 1, 2003

Study Completion

February 1, 2005

Last Updated

November 29, 2007

Record last verified: 2007-11

Locations

US(6)