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Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer

NCT ID: NCT00092001

Last Updated: 2008-10-16

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

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-03-31

Brief Summary

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The purpose of this study is to test whether SU011248 has activity and is safe in patients with metastatic non-small cell lung cancer (NSCLC) who have failed a platinum-containing regimen and docetaxel.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Keywords

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Non-small cell lung cancer, carcinoma, sunitinib, Phase 2

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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1

Group Type EXPERIMENTAL

Sunitinib

Intervention Type DRUG

Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.

Interventions

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Sunitinib

Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.

Intervention Type DRUG

Other Intervention Names

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Sutent, SU011248

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed advanced or metastatic Non-Small Cell Lung Cancer that cannot be cured with surgery, radiation, or combination thereof
* No more than 2 prior chemotherapy treatments including treatment with a platinum containing therapy
* Evidence of measurable disease by radiographic technique
* Male or Female, 18 years or older
* ECOG performance status of 0 or 1
* Resolution of all acute toxicities of prior therapies
* Adequate organ function

Exclusion Criteria

* Major surgery or radiation therapy within 4 weeks
* Severe hemorrhage within 4 weeks
* Previous treatment with anti-angiogenesis agents
* Diagnosis of second malignancy within last five 5 years
* History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
* Known HIV
* Serious acute or chronic illness
* Current treatment on another clinical trial
* Pregnant or breastfeeding
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

Baltimore, Maryland, United States

Site Status

Pfizer Investigational Site

City of Saint Peters, Missouri, United States

Site Status

Pfizer Investigational Site

St Louis, Missouri, United States

Site Status

Pfizer Investigational Site

St Louis, Missouri, United States

Site Status

Pfizer Investigational Site

Chapel Hill, North Carolina, United States

Site Status

Pfizer Investigational Site

Clinton, North Carolina, United States

Site Status

Pfizer Investigational Site

Goldsboro, North Carolina, United States

Site Status

Pfizer Investigational Site

Pollocksville, North Carolina, United States

Site Status

Pfizer Investigational Site

Wilson, North Carolina, United States

Site Status

Pfizer Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Charlottesville, Virginia, United States

Site Status

Pfizer Investigational Site

Orbassano (Torino), , Italy

Site Status

Pfizer Investigational Site

Badalona, Barcelona, Spain

Site Status

Pfizer Investigational Site

Barcelona, BARCELONA, Spain

Site Status

Countries

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United States Italy Spain

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181040&StudyName=Study%20Of%20SU011248%20In%20Patients%20With%20Metastatic%20Non-Small%20Cell%20Lung%20Cancer%20%20

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

Other Identifiers

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A6181040

Identifier Type: -

Identifier Source: org_study_id