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

Breast Neoplasms Clinical Trial

Official title:

A Phase 2 Study Of The Efficacy And Safety Of SU-014813 In Patients With Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322517
• Other study ID #: A6191007
• Status: Completed
• Phase: Phase 2
• First received: April 17, 2006
• Last updated: May 10, 2011
• Start date: April 2006
• Est. completion date: July 2009

Study information

• Verified date: May 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• SU014813
100 mg capsule/day for 6 cycle of 21 days

Locations

Country	Name	City	State
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Magdeburg
Germany	Pfizer Investigational Site	Marburg
Italy	Pfizer Investigational Site	Chieti Scalo
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Mirano (VE)
Italy	Pfizer Investigational Site	Udine
Netherlands	Pfizer Investigational Site	Amsterdam
Netherlands	Pfizer Investigational Site	Rotterdam
United Kingdom	Pfizer Investigational Site	Edinburgh
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Manchester	M20 4bx
United Kingdom	Pfizer Investigational Site	Sutton	Surrey
United States	Pfizer Investigational Site	Corinth	Mississippi
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Pasadena	California
United States	Pfizer Investigational Site	Santa Monica	California
United States	Pfizer Investigational Site	Southaven	Mississippi
United States	Pfizer Investigational Site	Valancia	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To assess onset and duration of tumor control and 1-year survival rate		AUG 2008	No
Secondary	To evaluate the safety of SU-014813To assess patient reported outcomes		AUG 2008	No
Secondary	To determine SU-014813 plasma trough concentration (Ctrough)		AUG 2008	No
Secondary	To explore the relationship between Ctrough and efficacy, safety, and biomarkers		AUG 2008	No
Secondary	To explore the correlations of cancer biomarkers with treatment-related outcomes		AUG 2008	No

External Links

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