Study Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases

NCT ID: NCT00372775

Last Updated: 2011-02-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-12-31

Brief Summary

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This study will evaluate the safety, tolerability and efficacy of SU011248 in patients with non-small cell lung cancer with brain metastases.

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sunitinib

Group Type EXPERIMENTAL

Sunitinib

Intervention Type DRUG

Sunitinib 37.5 mg daily by oral capsule in a continuous regimen until progression or unacceptable toxicity

Interventions

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Sunitinib

Sunitinib 37.5 mg daily by oral capsule in a continuous regimen until progression or unacceptable toxicity

Intervention Type DRUG

Other Intervention Names

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Sutent

Eligibility Criteria

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Inclusion Criteria

* Patients with radiologically proven brain metastases secondary to non-small cell lung cancer
* Received previous whole brain radiation therapy and none, 1 or 2 prior systemic therapy for the treatment of advanced/metastatic non-small cell lung cancer

Exclusion Criteria

* Patients with brainstem lesions, spinal cord compression. carcinomatous meningitis, or leptomeningeal disease.
* Brain metastases \>4 cm in any linear direction
* Intracranial or intratumoral hemorrhage
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Norwalk, Connecticut, United States

Site Status

Pfizer Investigational Site

Cocoa Beach, Florida, United States

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Pfizer Investigational Site

Merritt Island, Florida, United States

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Pfizer Investigational Site

Titusville, Florida, United States

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Pfizer Investigational Site

City of Saint Peters, Missouri, United States

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Pfizer Investigational Site

Creve Coeur, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Basking Ridge, New Jersey, United States

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Pfizer Investigational Site

Commack, New York, United States

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New York, New York, United States

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Pfizer Investigational Site

Sayre, Pennsylvania, United States

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Austin, Texas, United States

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Pfizer Investigational Site

Austin, Texas, United States

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Pfizer Investigational Site

Austin, Texas, United States

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Pfizer Investigational Site

Austin, Texas, United States

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Pfizer Investigational Site

Round Rock, Texas, United States

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Pfizer Investigational Site

Pessac, Be1 04495, France

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Pfizer Investigational Site

Saint-Priest-en-Jarez, France, France

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Pfizer Investigational Site

Marseille, , France

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Pfizer Investigational Site

Toulouse, , France

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Pfizer Investigational Site

Bologna, , Italy

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Pfizer Investigational Site

Genova, , Italy

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Pfizer Investigational Site

Orbassano (TO), , Italy

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Pfizer Investigational Site

Roma, , Italy

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Pfizer Investigational Site

Madrid, Madrid, Spain

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Pfizer Investigational Site

Valencia, Valencia, Spain

Site Status

Countries

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United States France Italy Spain

Related Links

Other Identifiers

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A6181092

Identifier Type: -

Identifier Source: org_study_id

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