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

This study has been completed.

First Received on November 17, 2003. Last Updated on November 28, 2007 History of Changes

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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Show 23 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Helen Eliopoulos, M.D.

Abbott

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00073112 History of Changes
Obsolete Identifiers:	NCT00080717
Other Study ID Numbers:	M02-416
Study First Received:	November 17, 2003
Last Updated:	November 28, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Carcinoma, Renal Cell
Colorectal Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site

Kidney Diseases
Urologic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on February 09, 2012