Study Of The Efficacy And Safety Of SU-014813 In Patients With Metastatic Breast Cancer

NCT ID: NCT00322517

Last Updated: 2011-05-17

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-07-31

Brief Summary

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To determine the antitumor efficacy and the safety of SU-014813 at a dose of 100 mg orally once daily in patients with Metastatic Breast Cancer

Detailed Description

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Conditions

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Breast Neoplasms

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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SU014813

Group Type EXPERIMENTAL

SU014813

Intervention Type DRUG

100 mg capsule/day for 6 cycle of 21 days

Interventions

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SU014813

100 mg capsule/day for 6 cycle of 21 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically proven diagnosis of metastatic breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent.
* Must have received prior treatment with an anthracycline and a taxane either concurrently or sequentially in the adjuvant and/or advanced disease treatment settings. Patients may have received as many as 2 other chemotherapy regimens in the advanced disease setting. Patients whose tumors are Her-2-positive must have received prior trastuzumab therapy. Prior hormonal therapy or immunotherapy in the adjuvant and/or advanced/metastatic disease settings is permitted. Prior treatment with surgery, radiotherapy, chemoembolization therapy, or cryotherapy is allowed if these therapies did not affect the areas of measurable disease.

Exclusion Criteria

* Prior treatment with \>/= 3 regimens of chemotherapy in the metastatic disease setting beyond those containing anthracyclines and taxanes
* Uncontrolled brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. Patients should have completed surgery or radiation therapy for existing brain metastases, should not have documented increase in size over the previous 3 months and should be asymptomatic
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

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

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

Pasadena, California, United States

Site Status

Pfizer Investigational Site

Santa Monica, California, United States

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Pfizer Investigational Site

Valancia, California, United States

Site Status

Pfizer Investigational Site

Corinth, Mississippi, United States

Site Status

Pfizer Investigational Site

Southaven, Mississippi, United States

Site Status

Pfizer Investigational Site

Memphis, Tennessee, United States

Site Status

Pfizer Investigational Site

Memphis, Tennessee, United States

Site Status

Pfizer Investigational Site

Hamburg, , Germany

Site Status

Pfizer Investigational Site

Magdeburg, , Germany

Site Status

Pfizer Investigational Site

Marburg, , Germany

Site Status

Pfizer Investigational Site

Chieti Scalo, , Italy

Site Status

Pfizer Investigational Site

Milan, , Italy

Site Status

Pfizer Investigational Site

Mirano (VE), , Italy

Site Status

Pfizer Investigational Site

Udine, , Italy

Site Status

Pfizer Investigational Site

Amsterdam, , Netherlands

Site Status

Pfizer Investigational Site

Rotterdam, , Netherlands

Site Status

Pfizer Investigational Site

Manchester, M20 4bx, United Kingdom

Site Status

Pfizer Investigational Site

Sutton, Surrey, United Kingdom

Site Status

Pfizer Investigational Site

Edinburgh, , United Kingdom

Site Status

Pfizer Investigational Site

London, , United Kingdom

Site Status

Pfizer Investigational Site

London, , United Kingdom

Site Status

Countries

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United States Germany Italy Netherlands United Kingdom

Related Links

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Other Identifiers

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A6191007

Identifier Type: -

Identifier Source: org_study_id

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