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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00319254
Recruitment Status : Completed
First Posted : April 27, 2006
Results First Posted : January 31, 2013
Last Update Posted : January 31, 2013
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE April 24, 2006
First Posted Date  ICMJE April 27, 2006
Results First Submitted Date  ICMJE October 4, 2012
Results First Posted Date  ICMJE January 31, 2013
Last Update Posted Date January 31, 2013
Study Start Date  ICMJE May 2006
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2012)
  • Progression-Free Survival (PFS) Rate [ Time Frame: Baseline up to Week 16 ]
    PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from death case report forms (CRFs). Percentage of participants who had not experienced progression or death by Week 16 is reported.
  • Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 30 days after last dose of study treatment ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2006)
Determine the rate of progression free survival (PFS) at 16 weeks.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2012)
  • Overall Survival (OS) [ Time Frame: Baseline up to Year 2 ]
    OS was estimated by Kaplan-Meier method. Survival was defined as the time period from the date of first dose of study treatment to the date of death, censored at the participant's last contact date. Percentage of participants who were still alive at 2 years is reported.
  • Percentage of Participants With Objective Response (OR) [ Time Frame: Baseline up to Year 1 ]
    Percentage of participants with OR was based on the assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to sponsor modified Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target and non-target lesions. Confirmed PR defined as more than or equal to (>=) 30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.
  • Percentage of Participants With Clinical Benefit [ Time Frame: Baseline up to end of treatment (Week 77) ]
    Clinical benefit was defined as a confirmed CR or PR, or stable disease (SD) for more than (>) 24 weeks as the best response before the first evidence of progressive disease (PD). A participant demonstrating CR, PR, or SD >24 weeks at any time while on study was counted in the numerator.
  • Number of Participants With Change From Baseline in Laboratory Test Results [ Time Frame: Baseline up to end of treatment (Week 77) ]
    Number of participants with potentially clinically significant (PCS) laboratory values are reported. Criteria for PCS laboratory values include: aspartate aminotransferase (AST), alanine aminotransferase (ALT) >5*upper limit of normal(ULN) milliunit/milliliter(mU/mL); total bilirubin >3*ULN micromole/L; sodium <130, magnesium <0.4 and >1.23 millimole/L; lipase >2*ULN microkats/L; neutrophils <1*10^9/L. Participants meeting at least 1 PCS criteria are reported.
  • Number of Participants With Change From Baseline in Electrocardiogram (ECG) [ Time Frame: Baseline up to end of treatment (Week 77) ]
    Number of participants with potentially clinically significant (PCS) ECG findings are reported. Criteria for PCS ECG findings include: no sinus rhythm; heart rate >=120 beats per minute (bpm) or increase >=15 bpm; QT interval corrected using Bazett's formula (QTcB) >60 milliseconds (msec) change from baseline; and overall ECG evaluation not normal.
  • Number of Participants With Change From Baseline in Vital Signs, Physical Examinations, and Ophthalmological Examinations [ Time Frame: Baseline up to end of treatment (Week 77) ]
    Number of participants with potentially clinically significant (PCS) vital signs and physical examinations are reported. Criteria for PCS vital signs include: respiratory rate >25 breaths/minute and PCS physical examinations include: an increase or decrease from baseline of >=7% in body weight.
  • Concomitant Medications Used for Management of Adverse Events (AEs) [ Time Frame: Day 1 up to end of treatment (Week 77) ]
    Number of participants taking any non-study medications which were administered from Study Day 1 to last dose of study treatment (Week 77) as a management of an AE were to be reported.
  • Change From Baseline in Karnofsky Performance Status (KPS) at Week 1, 4, 8, 12, 16, Every 8 Weeks Thereafter and 14 Days After Last Dose of Study Treatment [ Time Frame: Baseline, Weeks 1,4,8,12,16, every 8 weeks thereafter and 14 days after last dose of study treatment ]
    KPS: 11 level score ranged 100 to 0, to assess functional impairment. 100:Normal; 90:Able to carry on normal activity; 80:Normal activity with effort, some signs or symptoms of disease; 70:Cares for self, unable to carry on normal activity or to do active work; 60:Requires occasional assistance but is able to care for most of needs; 50:Requires considerable assistance and frequent medical care; 40:Disabled,requires special care and assistance; 30:Severely disabled; hospitalization indicated although death is not imminent; 20:Very sick; 10:Morbibund,fatal processes progressing rapidly; 0:Death.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2006)
  • Determine the safety profile of 400mg/day
  • Determine the rate of objective response within 1 year and the survival rate at 3 years after beginning SKI-606 treatment
  • Determine the pharmacokinetics (PK) of SKI-606 in this patient population.
Current Other Pre-specified Outcome Measures
 (submitted: December 21, 2012)
Population Pharmacokinetics (PK) [ Time Frame: Pre-dose, 2, 7, 20 hours post-dose on Day 1 of Week 4 and pre-dose on Day 1 of Weeks 1, 8, 12, 16, and 24 ]
Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Original Other Pre-specified Outcome Measures Not Provided
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 Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2012)
Original Enrollment  ICMJE
 (submitted: April 26, 2006)
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
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 Call Center Pfizer
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