Study Of SU011248 In Combination With Paclitaxel In Patients With Metastatic Breast Cancer

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

Tracking Information

• First Submitted Date: September 12, 2005
• First Posted Date: September 15, 2005
• Last Update Posted Date: January 27, 2009
• Study Start Date: September 2005
• Actual Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 21, 2007): Safety of the combination of SU011248 and paclitaxel [ Time Frame: 9/05-7/07 ]
• Original Primary Outcome Measures (submitted: September 12, 2005): Safety of the combination of SU011248 and paclitaxel

Current Secondary Outcome Measures (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 (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: Study Of SU011248 In Combination With Paclitaxel In Patients With Metastatic Breast Cancer
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Breast Neoplasms

Intervention

• 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

Experimental: A

Interventions:

• Drug: SU011248
• Drug: Paclitaxel

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 3, 2008): 22
• Original Enrollment (submitted: September 12, 2005): 20
• Actual Study Completion Date: August 2007
• Actual Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00174434
• Other Study ID Numbers: A6181073
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: October 2008