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

Renal Cell Cancer Clinical Trial

Official title:

A Phase 2 Study of ABT-751 in Subjects With Refractory Colorectal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00073112
• Other study ID #: M02-416
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2003
• Last updated: November 28, 2007
• Start date: August 2003
• Est. completion date: September 2006

Study information

• Verified date: November 2007
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00080717

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Cancer

Intervention

Drug:
• ABT-751

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Health Science Centre	Halifax	Nova Scotia
Canada	McMaster University	Hamilton	Ontario
Canada	McGill University	Montreal	Quebec
Canada	B.C. Vancouver Cancer Agency	Vancouver	British Columbia
United States	Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	US Oncology Inc Raleigh Hematology Oncology Clinic	Cary	North Carolina
United States	University of Chicago Medical Center	Chicago	Illinois
United States	US Oncology Inc Rocky Mountain Cancer Centers	Denver	Colorado
United States	US Oncology Inc Cancer Centers of the Carolinas	Greenville	South Carolina
United States	US Oncology Inc Dayton Oncology & Hematology P.A.	Kettering	Ohio
United States	UCLA School of Medicine	Los Angeles	California
United States	West Cancer Clinic	Memphis	Tennessee
United States	Oncology Hematology Group of South Florida	Miami	Florida
United States	Clinical Trials + Research Associates	Montebello	California
United States	Vanderbilt Ingram Cancer Center	Nashville	Tennessee
United States	US Oncology Inc Florida Cancer Institute	New Port Richey	Florida
United States	US Oncology Inc Ocala Oncology Center	Ocala	Florida
United States	US Oncology Inc Cancer Care Accociates-Mercy Campus	Oklahoma City	Oklahoma
United States	US Oncology Inc Cancer Centers of Florida, P.A.	Orlando	Florida
United States	US Oncology Inc Cancer Care Northwest-North	Spokane	Washington
United States	Arizona Cancer Research Center	Tucson	Arizona
United States	US Oncology Inc Tyler Cancer Center	Tyler	Texas
United States	US Oncology Inc Northwest Cancer Specialists	Vancouver	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate in subjects with RCC		1 year
Secondary	Time to Tumor Progression (TTP)		1 year
Secondary	Survival		2 years
Secondary	Toxicities associated with treatment administration		1 year