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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00322517
First received: April 17, 2006
Last updated: May 10, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Breast Neoplasms
Drug: SU014813
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study Of The Efficacy And Safety Of SU-014813 In Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess onset and duration of tumor control and 1-year survival rate [ Time Frame: AUG 2008 ] [ Designated as safety issue: No ]
  • To evaluate the safety of SU-014813To assess patient reported outcomes [ Time Frame: AUG 2008 ] [ Designated as safety issue: No ]
  • To determine SU-014813 plasma trough concentration (Ctrough) [ Time Frame: AUG 2008 ] [ Designated as safety issue: No ]
  • To explore the relationship between Ctrough and efficacy, safety, and biomarkers [ Time Frame: AUG 2008 ] [ Designated as safety issue: No ]
  • To explore the correlations of cancer biomarkers with treatment-related outcomes [ Time Frame: AUG 2008 ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: April 2006
Study Completion Date: July 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SU014813 Drug: SU014813
100 mg capsule/day for 6 cycle of 21 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322517

Locations
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90095
Pfizer Investigational Site
Pasadena, California, United States, 91105
Pfizer Investigational Site
Santa Monica, California, United States, 90404
Pfizer Investigational Site
Valancia, California, United States, 91355
United States, Mississippi
Pfizer Investigational Site
Corinth, Mississippi, United States, 38834
Pfizer Investigational Site
Southaven, Mississippi, United States, 38671
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38104
Pfizer Investigational Site
Memphis, Tennessee, United States, 38120
Germany
Pfizer Investigational Site
Hamburg, Germany, 20246
Pfizer Investigational Site
Magdeburg, Germany, 39130
Pfizer Investigational Site
Marburg, Germany, 35043
Italy
Pfizer Investigational Site
Chieti Scalo, Italy, 66013
Pfizer Investigational Site
Milano, Italy, 20133
Pfizer Investigational Site
Mirano (VE), Italy, 30035
Pfizer Investigational Site
Udine, Italy, 33100
Netherlands
Pfizer Investigational Site
Amsterdam, Netherlands, 1081 HV
Pfizer Investigational Site
Rotterdam, Netherlands, 3075 EA
United Kingdom
Pfizer Investigational Site
Manchester, M20 4bx, United Kingdom
Pfizer Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
Pfizer Investigational Site
Edinburgh, United Kingdom, EH4 2XU
Pfizer Investigational Site
London, United Kingdom, SE1 9RT
Pfizer Investigational Site
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00322517     History of Changes
Other Study ID Numbers: A6191007
Study First Received: April 17, 2006
Last Updated: May 10, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 29, 2014