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Study Evaluating SKI-606 (Bosutinib) In Subjects With Breast Cancer

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Duarte, California, 91010-3000 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms, Neoplasm Metastasis
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

- Stage IIIB, IIIC or IV breast cancer not curable with available therapy.

- Patients must have progressed after 1 but not more than 3 prior chemotherapy regimens.

- Life expectancy of at least 16 weeks.

- Ability to swallow whole capsules.

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

- Use of or requirement for bisphosphonates within 8 weeks prior to screening.

- Any other cancer within 5 years of screening, except for basal cell carcinoma or
cervical carcinoma in situ

- Uncontrolled cardiac disease including congestive heart failure, angina, heart attack,
etc.

- Recent or ongoing significant gastrointestinal disorder

NCT00319254
Pfizer
Completed
Study Evaluating SKI-606 (Bosutinib) In Subjects With Breast Cancer

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Study Evaluating SKI-606 (Bosutinib) In Subjects With Breast Cancer
Phase II Study Of SKI-606 In Subjects With Advanced Or Metastatic Breast Cancer
The purpose of this study is to determine if SKI-606 (Bosutinib) is effective in the treatment of advanced or metastatic breast cancer. Patients must have current Stage IIIB, IIIC or IV breast cancer and have progressed after 1 to 3 prior chemotherapy regimens.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Neoplasms
  • Neoplasm Metastasis
Drug: SKI-606 (Bosutinib)
SKI-606 (Bosutinib) 400mg once daily, for as long as tolerated or until disease progression.
Experimental: Advanced breast cancer
Intervention: Drug: SKI-606 (Bosutinib)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
February 2009
February 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Stage IIIB, IIIC or IV breast cancer not curable with available therapy.
  • Patients must have progressed after 1 but not more than 3 prior chemotherapy regimens.
  • Life expectancy of at least 16 weeks.
  • Ability to swallow whole capsules.

Exclusion Criteria:

  • Use of or requirement for bisphosphonates within 8 weeks prior to screening.
  • Any other cancer within 5 years of screening, except for basal cell carcinoma or cervical carcinoma in situ
  • Uncontrolled cardiac disease including congestive heart failure, angina, heart attack, etc.
  • Recent or ongoing significant gastrointestinal disorder
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   France,   Hong Kong,   Malta,   Poland,   Russian Federation,   Ukraine,   United States
China,   Ireland,   Italy,   United Kingdom
 
NCT00319254
3160A2-201
B1871014
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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