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

Last updated on May 12, 2018

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Study Location
Pfizer Investigational Site
Harvey, Illinois, 60426-4265 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- Candidate for treatment with paclitaxel.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prior chemotherapy in the advanced disease setting.

- HER2 positive disease unless previously treated with trastuzumab.

NCT00174434
Pfizer
Completed
Study Of SU011248 In Combination With Paclitaxel In Patients With Metastatic Breast Cancer

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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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Neoplasms
  • 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.
Experimental: A
Interventions:
  • Drug: SU011248
  • Drug: Paclitaxel
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
August 2007
August 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00174434
A6181073
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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