Clinical trial NCT00322517: Study Of The Efficacy And Safety Of SU-014813 In Patients With Metastatic Breast Cancer
Official title: A Phase 2 Study Of The Efficacy And Safety Of SU-014813 In Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-05-08
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: To determine the antitumor efficacy of single agent SU-014813 at a dose of 100 mg orally once daily in patients with MBC
timeFrame: June 2008
Secondary outcomes:
measure: To assess onset and duration of tumor control and 1-year survival rate
timeFrame: AUG 2008
measure: To evaluate the safety of SU-014813To assess patient reported outcomes
timeFrame: AUG 2008
measure: To determine SU-014813 plasma trough concentration (Ctrough)
timeFrame: AUG 2008
measure: To explore the relationship between Ctrough and efficacy, safety, and biomarkers
timeFrame: AUG 2008
measure: To explore the correlations of cancer biomarkers with treatment-related outcomes
timeFrame: AUG 2008
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Monica
country: United States
facility: Pfizer Investigational Site
state: California
city: Valancia
country: United States
facility: Pfizer Investigational Site
state: California
city: Corinth
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Southaven
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Magdeburg
country: Germany
facility: Pfizer Investigational Site
city: Marburg
country: Germany
facility: Pfizer Investigational Site
city: Chieti Scalo
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Mirano (VE)
country: Italy
facility: Pfizer Investigational Site
city: Udine
country: Italy
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Rotterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
state: M20 4bx
city: Sutton
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Edinburgh
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: