A Study of ABT-751 in Patients With Renal Cell Cancer
Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT00073112
Collaborator
(none)
60
23
37
2.6
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Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of ABT-751 in Subjects With Refractory Colorectal Carcinoma
Study Start Date
:
Aug 1, 2003
Actual Study Completion Date
:
Sep 1, 2006
Outcome Measures
Primary Outcome Measures
- Objective Response Rate in subjects with RCC [1 year]
Secondary Outcome Measures
- Time to Tumor Progression (TTP) [1 year]
- Survival [2 years]
- Toxicities associated with treatment administration [1 year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arizona Cancer Research Center | Tucson | Arizona | United States | 85712 |
| 2 | UCLA School of Medicine | Los Angeles | California | United States | 90024 |
| 3 | Clinical Trials + Research Associates | Montebello | California | United States | 90640 |
| 4 | US Oncology Inc Rocky Mountain Cancer Centers | Denver | Colorado | United States | 80218 |
| 5 | Oncology Hematology Group of South Florida | Miami | Florida | United States | |
| 6 | US Oncology Inc Florida Cancer Institute | New Port Richey | Florida | United States | 34652 |
| 7 | US Oncology Inc Ocala Oncology Center | Ocala | Florida | United States | 34474 |
| 8 | US Oncology Inc Cancer Centers of Florida, P.A. | Orlando | Florida | United States | 32806 |
| 9 | University of Chicago Medical Center | Chicago | Illinois | United States | 60637-1471 |
| 10 | Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | United States | 21231 |
| 11 | US Oncology Inc Raleigh Hematology Oncology Clinic | Cary | North Carolina | United States | 27511 |
| 12 | US Oncology Inc Dayton Oncology & Hematology P.A. | Kettering | Ohio | United States | 45409 |
| 13 | US Oncology Inc Cancer Care Accociates-Mercy Campus | Oklahoma City | Oklahoma | United States | 73120 |
| 14 | US Oncology Inc Cancer Centers of the Carolinas | Greenville | South Carolina | United States | 29615 |
| 15 | West Cancer Clinic | Memphis | Tennessee | United States | 38120 |
| 16 | Vanderbilt Ingram Cancer Center | Nashville | Tennessee | United States | 37232-6307 |
| 17 | US Oncology Inc Tyler Cancer Center | Tyler | Texas | United States | 75702 |
| 18 | US Oncology Inc Cancer Care Northwest-North | Spokane | Washington | United States | 99218 |
| 19 | US Oncology Inc Northwest Cancer Specialists | Vancouver | Washington | United States | 98684 |
| 20 | B.C. Vancouver Cancer Agency | Vancouver | British Columbia | Canada | V5Z 4E6CAN |
| 21 | Queen Elizabeth II Health Science Centre | Halifax | Nova Scotia | Canada | B3H2Y9 |
| 22 | McMaster University | Hamilton | Ontario | Canada | L8N 4A6 |
| 23 | McGill University | Montreal | Quebec | Canada |
Sponsors and Collaborators
- Abbott
Investigators
- Study Director: Helen Eliopoulos, M.D., Abbott
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00073112
Other Study ID Numbers:
- M02-416
- NCT00080717
First Posted:
Nov 18, 2003
Last Update Posted:
Nov 29, 2007
Last Verified:
Nov 1, 2007
Additional relevant MeSH terms: