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

Primary Purpose

Kidney Neoplasms

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SU-011,248
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Neoplasms

Eligibility Criteria

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

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

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.

Full Information

First Posted
February 12, 2003
Last Updated
May 4, 2007
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00054886
Brief Title
Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer
Official Title
Phase II Study Of Single-Agent SU011248 In The Second-Line Treatment Of Patients With Metastatic Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Neoplasms

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SU-011,248
Primary Outcome Measure Information:
Title
The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pfizer Investigational Site
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Pfizer Investigational Site
City
Monterey Park
State/Province
California
ZIP/Postal Code
91754
Country
United States
Facility Name
Pfizer Investigational Site
City
Northridge
State/Province
California
ZIP/Postal Code
91328
Country
United States
Facility Name
Pfizer Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Pfizer Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Pfizer Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Pfizer Investigational Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Pfizer Investigational Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28410911
Citation
de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
Results Reference
derived
PubMed Identifier
27238653
Citation
Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
Results Reference
derived
PubMed Identifier
25577718
Citation
Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=RTKC-0511-014&StudyName=Study+of+the+Safety+and+Efficacy+of+SU%2D011%2C248+in+Adult+Patients+With+Advanced+Kidney+Cancer
Description
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Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer

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