Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00054886
First received: February 12, 2003
Last updated: May 4, 2007
Last verified: July 2006
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Purpose
The primary goal of the study is to evaluate the effectiveness and safety of SU-011,248 as a treatment for metastatic kidney cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Neoplasms |
Drug: SU-011,248 |
Phase 2 |
| 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: | Phase II Study Of Single-Agent SU011248 In The Second-Line Treatment Of Patients With Metastatic Renal Cell Carcinoma |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%.
Secondary Outcome Measures:
- The secondary endpoints included time to progression (TTP) and overall survival (OS). The median TTP for the study was 8.7 months and the median OS was 16.4 months. SU011248 was generally well tolerated.
| Estimated Enrollment: | 63 |
| Study Start Date: | January 2003 |
| Study Completion Date: | August 2004 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Eligible patients must be at least 18 years of age with a diagnosis of metastatic kidney cancer.
- The patient's kidney cancer must have gotten worse during/after previous cytokine-based therapy was given.
- Any side effects from prior therapy must have subsided, and blood and urine tests must show adequate bone marrow, liver, and kidney function
Exclusion Criteria:
- Prior treatment with any systemic therapy other than 1 prior cytokine-based treatment regimen;
- Prior surgical resection of or irradiation to the only site of measurable disease;
- Ongoing severe hematuria;
- Other active second malignancy;
- Cardiovascular diseases or conditions within the last 12 months;
- Known brain metastases;
- Known HIV-positive or AIDS-related illness;
- Pregnant or breast-feeding women;
- Current participation in other clinical trials;
- Other severe acute or chronic medical conditions.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054886
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054886
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90095 | |
| Pfizer Investigational Site | |
| Mission Hills, California, United States, 91345 | |
| Pfizer Investigational Site | |
| Monterey Park, California, United States, 91754 | |
| Pfizer Investigational Site | |
| Northridge, California, United States, 91328 | |
| Pfizer Investigational Site | |
| San Francisco, California, United States, 94115 | |
| Pfizer Investigational Site | |
| San Francisco, California, United States, 94121 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02114 | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Nevada | |
| Pfizer Investigational Site | |
| Henderson, Nevada, United States, 89052 | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89109 | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89128 | |
| United States, New York | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10021 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Madison, Wisconsin, United States, 53792 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00054886 History of Changes |
| Other Study ID Numbers: | RTKC-0511-014 |
| Study First Received: | February 12, 2003 |
| Last Updated: | May 4, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Kidney Neoplasms Kidney Diseases Neoplasms Neoplasms by Site Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Sunitinib |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents Growth Inhibitors Growth Substances Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 25, 2015