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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00322517
• Date of registration: 17/04/2006
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: Study Of The Efficacy And Safety Of SU-014813 In Patients With Metastatic Breast Cancer
• Scientific title: A Phase 2 Study Of The Efficacy And Safety Of SU-014813 In Patients With Metastatic Breast Cancer
• Date of first enrolment: April 2006
• Target sample size: 90
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00322517
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Germany, Italy, Netherlands, United Kingdom, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Neoplasms

Intervention(s)

Drug: SU014813

Primary Outcome(s)

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

Secondary Outcome(s)

To evaluate the safety of SU-014813To assess patient reported outcomes [Time Frame: AUG 2008]

To explore the relationship between Ctrough and efficacy, safety, and biomarkers [Time Frame: AUG 2008]

To assess onset and duration of tumor control and 1-year survival rate [Time Frame: AUG 2008]

To determine SU-014813 plasma trough concentration (Ctrough) [Time Frame: AUG 2008]

To explore the correlations of cancer biomarkers with treatment-related outcomes [Time Frame: AUG 2008]

Secondary ID(s)

A6191007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors