NCT00322517

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2006

Typical duration for phase_2

Geographic Reach
5 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2006

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 8, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

May 17, 2011

Status Verified

May 1, 2011

Enrollment Period

2.2 years

First QC Date

April 17, 2006

Last Update Submit

May 10, 2011

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Study Arms (1)

SU014813

EXPERIMENTAL
Drug: SU014813

Interventions

SU014813DRUG

100 mg capsule/day for 6 cycle of 21 days

SU014813

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Pfizer Investigational Site

Los Angeles, California, 90095, United States

Location

Pfizer Investigational Site

Pasadena, California, 91105, United States

Location

Pfizer Investigational Site

Santa Monica, California, 90404, United States

Location

Pfizer Investigational Site

Valancia, California, 91355, United States

Location

Pfizer Investigational Site

Corinth, Mississippi, 38834, United States

Location

Pfizer Investigational Site

Southaven, Mississippi, 38671, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38104, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38120, United States

Location

Pfizer Investigational Site

Hamburg, 20246, Germany

Location

Pfizer Investigational Site

Magdeburg, 39130, Germany

Location

Pfizer Investigational Site

Marburg, 35043, Germany

Location

Pfizer Investigational Site

Chieti Scalo, 66013, Italy

Location

Pfizer Investigational Site

Milan, 20133, Italy

Location

Pfizer Investigational Site

Mirano (VE), 30035, Italy

Location

Pfizer Investigational Site

Udine, 33100, Italy

Location

Pfizer Investigational Site

Amsterdam, 1081 HV, Netherlands

Location

Pfizer Investigational Site

Rotterdam, 3075 EA, Netherlands

Location

Pfizer Investigational Site

Manchester, M20 4bx, United Kingdom

Location

Pfizer Investigational Site

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Pfizer Investigational Site

Edinburgh, EH4 2XU, United Kingdom

Location

Pfizer Investigational Site

London, SE1 9RT, United Kingdom

Location

Pfizer Investigational Site

London, SW3 6JJ, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 17, 2006

First Posted

May 8, 2006

Study Start

April 1, 2006

Primary Completion

June 1, 2008

Study Completion

July 1, 2009

Last Updated

May 17, 2011

Record last verified: 2011-05

Locations

GB(5)NL(2)US(8)DE(3)IT(4)