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

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

MedlinePlus related topics:

Cancer

Drug Information available for:

ABT 751 E 7010

U.S. FDA Resources

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

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

Show 23 Study Locations

Sponsors and Collaborators

Abbott

Investigators


Study Director:	Helen Eliopoulos, M.D.	Abbott

More Information

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

Study placed in the following topic categories:

Urologic Diseases

Kidney Neoplasms

Carcinoma, Renal Cell

Urogenital Neoplasms

Renal cancer

Kidney Diseases

Kidney cancer

Urologic Neoplasms

Adenocarcinoma

Urinary tract neoplasm

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 30, 2008

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