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

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ClinicalTrials.gov Identifier: NCT00322517
Recruitment Status : Completed
First Posted : May 8, 2006
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE April 17, 2006
First Posted Date  ICMJE May 8, 2006
Last Update Posted Date May 17, 2011
Study Start Date  ICMJE April 2006
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 5, 2006)
To determine the antitumor efficacy of single agent SU-014813 at a dose of 100 mg orally once daily in patients with MBC
Change History Complete list of historical versions of study NCT00322517 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2009)
  • To assess onset and duration of tumor control and 1-year survival rate [ Time Frame: AUG 2008 ]
  • To evaluate the safety of SU-014813To assess patient reported outcomes [ Time Frame: AUG 2008 ]
  • To determine SU-014813 plasma trough concentration (Ctrough) [ Time Frame: AUG 2008 ]
  • To explore the relationship between Ctrough and efficacy, safety, and biomarkers [ Time Frame: AUG 2008 ]
  • To explore the correlations of cancer biomarkers with treatment-related outcomes [ Time Frame: AUG 2008 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2006)
  • To assess onset and duration of tumor control and 1-year survival rate
  • To evaluate the safety of SU-014813
  • To assess patient reported outcomes
  • To determine SU-014813 plasma trough concentration (Ctrough)
  • To explore the relationship between Ctrough and efficacy, safety, and biomarkersTo explore the correlations of cancer biomarkers with treatment-related outcomes
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of The Efficacy And Safety Of SU-014813 In Patients With Metastatic Breast Cancer
Official Title  ICMJE A Phase 2 Study Of The Efficacy And Safety Of SU-014813 In Patients With Metastatic Breast Cancer
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE Drug: SU014813
100 mg capsule/day for 6 cycle of 21 days
Study Arms  ICMJE Experimental: SU014813
Intervention: Drug: SU014813
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2009)
90
Original Enrollment  ICMJE
 (submitted: May 5, 2006)
66
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Italy,   Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00322517
Other Study ID Numbers  ICMJE A6191007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP