Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

February 12, 2003

Last Updated Date

May 4, 2007

Start Date ^ICMJE

January 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00054886 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer

Official Title ^ICMJE

Phase II Study Of Single-Agent SU011248 In The Second-Line Treatment Of Patients With Metastatic Renal Cell Carcinoma

Brief Summary

The primary goal of the study is to evaluate the effectiveness and safety of SU-011,248 as a treatment for metastatic kidney cancer.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Kidney Neoplasms

Intervention ^ICMJE

Drug: SU-011,248

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00054886

Responsible Party

Study ID Numbers ^ICMJE

RTKC-0511-014

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

July 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP