Study Of SU011248 In Combination With Paclitaxel In Patients With Metastatic Breast Cancer
A Phase 1 Study Of Paclitaxel In Combination With SU011248 For Patients With Breast Cancer As First-Line Treatment In The Advanced Disease Setting
1 other identifier
interventional
22
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2005
6 active sites
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
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedJanuary 27, 2009
October 1, 2008
1.9 years
September 12, 2005
January 26, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Safety of the combination of SU011248 and paclitaxel
9/05-7/07
Secondary Outcomes (3)
Pharmacokinetics of each medication
9/05-7/07
Objective disease response
9/05-7/07
Progression-free survival.
9/05-7/07
Study Arms (1)
A
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Breast cancer with evidence of unresectable, locally recurrent or metastatic disease.
- Candidate for treatment with paclitaxel.
You may not qualify if:
- Prior chemotherapy in the advanced disease setting.
- HER2 positive disease unless previously treated with trastuzumab.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (6)
Pfizer Investigational Site
Harvey, Illinois, 60426-4265, United States
Pfizer Investigational Site
Harvey, Illinois, 60426, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46202, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46290, United States
Pfizer Investigational Site
Munster, Indiana, 46321, United States
Pfizer Investigational Site
New York, New York, 10021, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
September 1, 2005
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
January 27, 2009
Record last verified: 2008-10