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

NCT00319254

Last updated date
Study Location
Pfizer Investigational Site
Duarte, California, 91010-3000, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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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

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating SKI-606 (Bosutinib) In Subjects With Breast Cancer
Official Title  ICMJE Phase II Study Of SKI-606 In Subjects With Advanced Or Metastatic Breast Cancer
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Neoplasms
  • Neoplasm Metastasis
Intervention  ICMJE Drug: SKI-606 (Bosutinib)
SKI-606 (Bosutinib) 400mg once daily, for as long as tolerated or until disease progression.
Study Arms  ICMJE Experimental: Advanced breast cancer
Intervention: Drug: SKI-606 (Bosutinib)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2012)
75
Original Enrollment  ICMJE
 (submitted: April 26, 2006)
60
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   France,   Hong Kong,   Malta,   Poland,   Russian Federation,   Ukraine,   United States
Removed Location Countries China,   Ireland,   Italy,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00319254
Other Study ID Numbers  ICMJE 3160A2-201
B1871014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP