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

Primary Purpose

Renal Cell Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABT-751
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Cancer Research Center
  • UCLA School of Medicine
  • Clinical Trials + Research Associates
  • US Oncology Inc Rocky Mountain Cancer Centers
  • Oncology Hematology Group of South Florida
  • US Oncology Inc Florida Cancer Institute
  • US Oncology Inc Ocala Oncology Center
  • US Oncology Inc Cancer Centers of Florida, P.A.
  • University of Chicago Medical Center
  • Sidney Kimmel Comprehensive Cancer Center
  • US Oncology Inc Raleigh Hematology Oncology Clinic
  • US Oncology Inc Dayton Oncology & Hematology P.A.
  • US Oncology Inc Cancer Care Accociates-Mercy Campus
  • US Oncology Inc Cancer Centers of the Carolinas
  • West Cancer Clinic
  • Vanderbilt Ingram Cancer Center
  • US Oncology Inc Tyler Cancer Center
  • US Oncology Inc Cancer Care Northwest-North
  • US Oncology Inc Northwest Cancer Specialists
  • B.C. Vancouver Cancer Agency
  • Queen Elizabeth II Health Science Centre
  • McMaster University
  • McGill University

Outcomes

Primary Outcome Measures

Objective Response Rate in subjects with RCC

Secondary Outcome Measures

Time to Tumor Progression (TTP)
Survival
Toxicities associated with treatment administration

Full Information

First Posted
November 17, 2003
Last Updated
November 28, 2007
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00073112
Brief Title
A Study of ABT-751 in Patients With Renal Cell Cancer
Official Title
A Phase 2 Study of ABT-751 in Subjects With Refractory Colorectal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ABT-751
Primary Outcome Measure Information:
Title
Objective Response Rate in subjects with RCC
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time to Tumor Progression (TTP)
Time Frame
1 year
Title
Survival
Time Frame
2 years
Title
Toxicities associated with treatment administration
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Eliopoulos, M.D.
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Cancer Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Clinical Trials + Research Associates
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
US Oncology Inc Rocky Mountain Cancer Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Oncology Hematology Group of South Florida
City
Miami
State/Province
Florida
Country
United States
Facility Name
US Oncology Inc Florida Cancer Institute
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
US Oncology Inc Ocala Oncology Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
US Oncology Inc Cancer Centers of Florida, P.A.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1471
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
US Oncology Inc Raleigh Hematology Oncology Clinic
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
Facility Name
US Oncology Inc Dayton Oncology & Hematology P.A.
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
US Oncology Inc Cancer Care Accociates-Mercy Campus
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
US Oncology Inc Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
West Cancer Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Vanderbilt Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6307
Country
United States
Facility Name
US Oncology Inc Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
US Oncology Inc Cancer Care Northwest-North
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
US Oncology Inc Northwest Cancer Specialists
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
B.C. Vancouver Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6CAN
Country
Canada
Facility Name
Queen Elizabeth II Health Science Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2Y9
Country
Canada
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

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

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