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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00319254
Registration number
NCT00319254
Ethics application status
Date submitted
24/04/2006
Date registered
27/04/2006
Date last updated
31/01/2013
Titles & IDs
Public title
Study Evaluating SKI-606 (Bosutinib) In Subjects With Breast Cancer
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Scientific title
Phase II Study Of SKI-606 In Subjects With Advanced Or Metastatic Breast Cancer
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Secondary ID [1]
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B1871014
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Secondary ID [2]
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3160A2-201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms
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Neoplasm Metastasis
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SKI-606 (Bosutinib)
Experimental: Advanced breast cancer -
Treatment: Drugs: SKI-606 (Bosutinib)
SKI-606 (Bosutinib) 400mg once daily, for as long as tolerated or until disease progression.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS) Rate
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline up to Week 16
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Primary outcome [2]
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Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline up to 30 days after last dose of study treatment
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline up to Year 2
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Secondary outcome [2]
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Percentage of Participants With Objective Response (OR)
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline up to Year 1
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Secondary outcome [3]
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Percentage of Participants With Clinical Benefit
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline up to end of treatment (Week 77)
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Secondary outcome [4]
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Number of Participants With Change From Baseline in Laboratory Test Results
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline up to end of treatment (Week 77)
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Secondary outcome [5]
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Number of Participants With Change From Baseline in Electrocardiogram (ECG)
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline up to end of treatment (Week 77)
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Secondary outcome [6]
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Number of Participants With Change From Baseline in Vital Signs, Physical Examinations, and Ophthalmological Examinations
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline up to end of treatment (Week 77)
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Secondary outcome [7]
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Concomitant Medications Used for Management of Adverse Events (AEs)
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Assessment method [7]
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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.
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Timepoint [7]
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Day 1 up to end of treatment (Week 77)
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Secondary outcome [8]
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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
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline, Weeks 1,4,8,12,16, every 8 weeks thereafter and 14 days after last dose of study treatment
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2009
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Sample size
Target
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Accrual to date
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Final
75
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Pfizer Investigational Site - Darlinghurst
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Ohio
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Country [4]
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France
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State/province [4]
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Dijon
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Country [5]
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France
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State/province [5]
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Saint-Herblain
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Country [6]
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Hong Kong
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State/province [6]
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Pokfulam
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Country [7]
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Malta
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State/province [7]
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Floriana
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Country [8]
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Poland
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State/province [8]
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Lodz
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Country [9]
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Poland
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State/province [9]
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Wroclaw
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Country [10]
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Russian Federation
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State/province [10]
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Moscow
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Country [11]
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Ukraine
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State/province [11]
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Dnipropetrovsk
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Country [12]
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Ukraine
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State/province [12]
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Sumy
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Country [13]
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Ukraine
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State/province [13]
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Uzhgorod
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00319254
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00319254
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