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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00174434
• Date of registration: 12/09/2005
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: Study Of SU011248 In Combination With Paclitaxel In Patients With Metastatic Breast Cancer
• Scientific 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
• Date of first enrolment: September 2005
• Target sample size: 22
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00174434
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Breast Neoplasms

Intervention(s)

Drug: SU011248

Drug: Paclitaxel

Primary Outcome(s)

Safety of the combination of SU011248 and paclitaxel [Time Frame: 9/05-7/07]

Secondary Outcome(s)

Progression-free survival. [Time Frame: 9/05-7/07]

Pharmacokinetics of each medication [Time Frame: 9/05-7/07]

Objective disease response [Time Frame: 9/05-7/07]

Secondary ID(s)

A6181073

Source(s) of Monetary Support

Please refer to primary and secondary sponsors