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

NCT ID: NCT00054886

Last Updated: 2007-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-08-31

Brief Summary

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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

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Conditions

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Kidney Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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SU-011,248

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

Mission Hills, California, United States

Site Status

Pfizer Investigational Site

Monterey Park, California, United States

Site Status

Pfizer Investigational Site

Northridge, California, United States

Site Status

Pfizer Investigational Site

San Francisco, California, United States

Site Status

Pfizer Investigational Site

San Francisco, California, United States

Site Status

Pfizer Investigational Site

Boston, Massachusetts, United States

Site Status

Pfizer Investigational Site

Boston, Massachusetts, United States

Site Status

Pfizer Investigational Site

Ann Arbor, Michigan, United States

Site Status

Pfizer Investigational Site

Henderson, Nevada, United States

Site Status

Pfizer Investigational Site

Las Vegas, Nevada, United States

Site Status

Pfizer Investigational Site

Las Vegas, Nevada, United States

Site Status

Pfizer Investigational Site

New York, New York, United States

Site Status

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28410911 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27238653 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25577718 (View on PubMed)

Related Links

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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

To obtain contact information for a study center near you, click here.

Other Identifiers

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RTKC-0511-014

Identifier Type: -

Identifier Source: org_study_id