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

Phase 2

Completed

• Conditions: Breast Neoplasms
• Interventions: Drug: SU014813

• Registration Number: NCT00322517
• Lead Sponsor: Pfizer

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-17
• Study First Submitted QC: 2006-05-05
• Study First Posted: 2006-05-08
• Primary Completion: 2008-06
• Disposition First Submitted: 2009-05-09
• Disposition First Submitted QC: 2009-05-09
• Study Completion: 2009-07
• Disposition First Posted: 2009-09-28
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-10
• Last Update Posted: 2011-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SU014813	SU014813	-

Primary Outcome Measures

Name	Time	Method
To determine the antitumor efficacy of single agent SU-014813 at a dose of 100 mg orally once daily in patients with MBC	June 2008

Secondary Outcome Measures

Name	Time	Method
To assess onset and duration of tumor control and 1-year survival rate	AUG 2008
To evaluate the safety of SU-014813To assess patient reported outcomes	AUG 2008
To determine SU-014813 plasma trough concentration (Ctrough)	AUG 2008
To explore the relationship between Ctrough and efficacy, safety, and biomarkers	AUG 2008
To explore the correlations of cancer biomarkers with treatment-related outcomes	AUG 2008

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 London, United Kingdom