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Trial record 1 of 1 for:    NCT00174434
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Study Of SU011248 In Combination With Paclitaxel In Patients With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00174434
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 27, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date January 27, 2009
Study Start Date  ICMJE September 2005
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Safety of the combination of SU011248 and paclitaxel [ Time Frame: 9/05-7/07 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Safety of the combination of SU011248 and paclitaxel
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
  • Pharmacokinetics of each medication [ Time Frame: 9/05-7/07 ]
  • Objective disease response [ Time Frame: 9/05-7/07 ]
  • Progression-free survival. [ Time Frame: 9/05-7/07 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Pharmacokinetics of each medication, objective disease response, progression-free survival.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of SU011248 In Combination With Paclitaxel In Patients With Metastatic Breast Cancer
Official Title  ICMJE A Phase 1 Study Of Paclitaxel In Combination With SU011248 For Patients With Breast Cancer As First-Line Treatment In The Advanced Disease Setting
Brief Summary This study is to evaluate the safety of SU011248 in combination with paclitaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
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: SU011248
    SU011248 provided as capsules. The starting dose is 25 mg orally, daily in a continuous regimen beginning on day 2. Dose rest for 1 week is allowed. Dose escalation to 37.5 mg po OD is allowed within the constraints of acceptable toxicity parameters. Dosing will continue for 1 year or until disease progression or unacceptable toxicity, whichever comes first.
    Other Name: sunitinib malate, Sutent
  • Drug: Paclitaxel
    Paclitaxel is provided as an intravenous infusion for 1 hour weekly for 3 weeks followed by a 1-week rest. The starting dose is 90 mg/m2. The weekly dose may be decreased to 65 mg/m2 in subsequent cycles based on tolerability. Dosing will continue for 1 year or until maximum benefit, disease progression or unacceptable toxicity, whichever comes first.
Study Arms  ICMJE Experimental: A
Interventions:
  • Drug: SU011248
  • Drug: Paclitaxel
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: October 3, 2008)
22
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
20
Actual Study Completion Date  ICMJE August 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Breast cancer with evidence of unresectable, locally recurrent or metastatic disease.
  • Candidate for treatment with paclitaxel.

Exclusion Criteria:

  • Prior chemotherapy in the advanced disease setting.
  • HER2 positive disease unless previously treated with trastuzumab.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00174434
Other Study ID Numbers  ICMJE A6181073
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 October 2008

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