A Study of ABT-751 in Patients With Renal Cell Cancer - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00073112

Purpose

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.

Condition	Intervention	Phase
Renal Cell Cancer	Drug: ABT-751	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 2 Study of ABT-751 in Subjects With Refractory Colorectal Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: E 7010 ABT 751

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Objective Response Rate in subjects with RCC [ Time Frame: 1 year ]

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	August 2003
Study Completion Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073112

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Locations

United States, Arizona
Arizona Cancer Research Center
Tucson, Arizona, United States, 85712
United States, California
Clinical Trials + Research Associates
Montebello, California, United States, 90640
UCLA School of Medicine
Los Angeles, California, United States, 90024
United States, Colorado
US Oncology Inc Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
United States, Florida
US Oncology Inc Ocala Oncology Center
Ocala, Florida, United States, 34474
US Oncology Inc Florida Cancer Institute
New Port Richey, Florida, United States, 34652
US Oncology Inc Cancer Centers of Florida, P.A.
Orlando, Florida, United States, 32806
Oncology Hematology Group of South Florida
Miami, Florida, United States
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637-1471
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
United States, North Carolina
US Oncology Inc Raleigh Hematology Oncology Clinic
Cary, North Carolina, United States, 27511
United States, Ohio
US Oncology Inc Dayton Oncology & Hematology P.A.
Kettering, Ohio, United States, 45409
United States, Oklahoma
US Oncology Inc Cancer Care Accociates-Mercy Campus
Oklahoma City, Oklahoma, United States, 73120
United States, South Carolina
US Oncology Inc Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29615
United States, Tennessee
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6307
West Cancer Clinic
Memphis, Tennessee, United States, 38120
United States, Texas
US Oncology Inc Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Washington
US Oncology Inc Cancer Care Northwest-North
Spokane, Washington, United States, 99218
US Oncology Inc Northwest Cancer Specialists
Vancouver, Washington, United States, 98684
Canada, British Columbia
B.C. Vancouver Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6CAN
Canada, Nova Scotia
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, Canada, B3H2Y9
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 4A6
Canada, Quebec
McGill University
Montreal, Quebec, Canada

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Helen Eliopoulos, M.D.

Abbott

More Information

No publications provided

Study ID Numbers:	M02-416
Study First Received:	November 17, 2003
Last Updated:	November 28, 2007
ClinicalTrials.gov Identifier:	NCT00073112 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell

Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 27, 2009