A Study of ABT-751 in Patients With Renal Cell Cancer
A Phase 2 Study of ABT-751 in Subjects With Refractory Colorectal Carcinoma
1 other identifier
interventional
60
2 countries
23
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 renal cell 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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2003
Typical duration for phase_2
23 active sites
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
CompletedFirst Submitted
Initial submission to the registry
November 17, 2003
CompletedFirst Posted
Study publicly available on registry
November 18, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedNovember 29, 2007
November 1, 2007
November 17, 2003
November 28, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate in subjects with RCC
1 year
Secondary Outcomes (3)
Time to Tumor Progression (TTP)
1 year
Survival
2 years
Toxicities associated with treatment administration
1 year
Interventions
Eligibility Criteria
You may qualify if:
- Renal Cell Carcinoma.
- Recurrent tumor.
- At least 6 weeks post-nephrectomy.
- 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.
- CNS metastasis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (23)
Arizona Cancer Research Center
Tucson, Arizona, 85712, United States
UCLA School of Medicine
Los Angeles, California, 90024, United States
Clinical Trials + Research Associates
Montebello, California, 90640, United States
US Oncology Inc Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Oncology Hematology Group of South Florida
Miami, Florida, United States
US Oncology Inc Florida Cancer Institute
New Port Richey, Florida, 34652, United States
US Oncology Inc Ocala Oncology Center
Ocala, Florida, 34474, United States
US Oncology Inc Cancer Centers of Florida, P.A.
Orlando, Florida, 32806, United States
University of Chicago Medical Center
Chicago, Illinois, 60637-1471, United States
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States
US Oncology Inc Raleigh Hematology Oncology Clinic
Cary, North Carolina, 27511, United States
US Oncology Inc Dayton Oncology & Hematology P.A.
Kettering, Ohio, 45409, United States
US Oncology Inc Cancer Care Accociates-Mercy Campus
Oklahoma City, Oklahoma, 73120, United States
US Oncology Inc Cancer Centers of the Carolinas
Greenville, South Carolina, 29615, United States
West Cancer Clinic
Memphis, Tennessee, 38120, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232-6307, United States
US Oncology Inc Tyler Cancer Center
Tyler, Texas, 75702, United States
US Oncology Inc Cancer Care Northwest-North
Spokane, Washington, 99218, United States
US Oncology Inc Northwest Cancer Specialists
Vancouver, Washington, 98684, United States
B.C. Vancouver Cancer Agency
Vancouver, British Columbia, V5Z 4E6CAN, Canada
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, B3H2Y9, Canada
McMaster University
Hamilton, Ontario, L8N 4A6, Canada
McGill University
Montreal, Quebec, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Helen Eliopoulos, M.D.
Abbott
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
September 1, 2006
Last Updated
November 29, 2007
Record last verified: 2007-11