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Exploratory Evaluation Of A Sequential Administration Of Docetaxel And SU011248 In Women With Advanced Breast Cancer


Phase 1
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

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Trial Information

Exploratory Evaluation Of A Sequential Administration Of Docetaxel And SU011248 In Women With Advanced Breast Cancer


Inclusion Criteria:



- Breast cancer with evidence of unresectable, locally recurrent or metastatic disease

- Candidate for treatment with docetaxel

Exclusion Criteria:

- Prior chemotherapy in the advanced disease setting

- Inflammatory breast cancer

- HER2 positive disease

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters

Outcome Time Frame:

1, 2, 4, 6, 8, 12, 24 hours postdose

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181100

NCT ID:

NCT00291577

Start Date:

July 2006

Completion Date:

February 2009

Related Keywords:

  • Breast Neoplasms
  • advanced
  • sunitinib (Sutent)
  • docetaxel
  • Phase 1B
  • Breast Neoplasms
  • Neoplasms

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