Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

June 2008

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6191007

NCT ID:

NCT00322517

Start Date:

April 2006

Completion Date:

July 2009

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteOlive Branch, Mississippi  38654