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AG-013736 In Combination With Docetaxel Versus Docetaxel Alone For Patients With Metastatic Breast Cancer

Last updated on May 12, 2018

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Study Location
Pfizer Investigational Site
Tucson, Arizona, 85724-5024 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
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

- Female patients with histologically/cytologically proven metastatic breast carcinoma
(stage IV, or recurrent with local or regional spread or distant metastatic disease)

- Adequate bone marrow, liver, and renal function

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

- Adjuvant chemotherapy given in the past 12 months

- Uncontrolled brain metastases

NCT00076024
Pfizer
Completed
AG-013736 In Combination With Docetaxel Versus Docetaxel Alone For Patients With Metastatic Breast Cancer

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AG-013736 In Combination With Docetaxel Versus Docetaxel Alone For Patients With Metastatic Breast Cancer
Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study Of AG-013736 In Combination With Docetaxel Versus Docetaxel Alone In Patients With Metastatic Breast Cancer Preceded By A Phase 1 Evaluation Of The Combination
The primary purpose of the study is to determine the time to progression of the combination of study drug (AG-013736) and docetaxel versus docetaxel alone in patients who have not received prior chemotherapy for metastatic breast cancer. The secondary purpose of the study is to determine the dose of study drug that can be given with docetaxel administered on an every 3 week schedule.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Breast Neoplasms
  • Drug: Placebo
    5 mg twice daily [bid] continuous dosing
  • Drug: Docetaxel
    Standard of care drug administration
  • Drug: AG-013736 (axitinib)
    5mg twice daily [bid] continuous dosing
  • Docetaxel + Placebo
    Docetaxel + Placebo
    Interventions:
    • Drug: Placebo
    • Drug: Docetaxel
  • Experimental: Docetaxel + AG-013736
    Docetaxel + AG-013736
    Interventions:
    • Drug: AG-013736 (axitinib)
    • Drug: Docetaxel
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
174
November 2008
January 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female patients with histologically/cytologically proven metastatic breast carcinoma (stage IV, or recurrent with local or regional spread or distant metastatic disease)
  • Adequate bone marrow, liver, and renal function

Exclusion Criteria:

  • Adjuvant chemotherapy given in the past 12 months
  • Uncontrolled brain metastases
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Czech Republic,   Germany,   India,   Italy,   Spain,   United Kingdom,   United States
 
 
NCT00076024
A4061010
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

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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1-800-718-1021

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