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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Phase II Study Of SKI-606 In Subjects With Advanced Or Metastatic Breast Cancer
Secondary ID [1] 0 0
B1871014
Secondary ID [2] 0 0
3160A2-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Neoplasm Metastasis 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) Rate
Timepoint [1] 0 0
Baseline up to Week 16
Primary outcome [2] 0 0
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Baseline up to 30 days after last dose of study treatment
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Baseline up to Year 2
Secondary outcome [2] 0 0
Percentage of Participants With Objective Response (OR)
Timepoint [2] 0 0
Baseline up to Year 1
Secondary outcome [3] 0 0
Percentage of Participants With Clinical Benefit
Timepoint [3] 0 0
Baseline up to end of treatment (Week 77)
Secondary outcome [4] 0 0
Number of Participants With Change From Baseline in Laboratory Test Results
Timepoint [4] 0 0
Baseline up to end of treatment (Week 77)
Secondary outcome [5] 0 0
Number of Participants With Change From Baseline in Electrocardiogram (ECG)
Timepoint [5] 0 0
Baseline up to end of treatment (Week 77)
Secondary outcome [6] 0 0
Number of Participants With Change From Baseline in Vital Signs, Physical Examinations, and Ophthalmological Examinations
Timepoint [6] 0 0
Baseline up to end of treatment (Week 77)
Secondary outcome [7] 0 0
Concomitant Medications Used for Management of Adverse Events (AEs)
Timepoint [7] 0 0
Day 1 up to end of treatment (Week 77)
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Baseline, Weeks 1,4,8,12,16, every 8 weeks thereafter and 14 days after last dose of study treatment

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2009
Sample size
Target
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
France
State/province [4] 0 0
Dijon
Country [5] 0 0
France
State/province [5] 0 0
Saint-Herblain
Country [6] 0 0
Hong Kong
State/province [6] 0 0
Pokfulam
Country [7] 0 0
Malta
State/province [7] 0 0
Floriana
Country [8] 0 0
Poland
State/province [8] 0 0
Lodz
Country [9] 0 0
Poland
State/province [9] 0 0
Wroclaw
Country [10] 0 0
Russian Federation
State/province [10] 0 0
Moscow
Country [11] 0 0
Ukraine
State/province [11] 0 0
Dnipropetrovsk
Country [12] 0 0
Ukraine
State/province [12] 0 0
Sumy
Country [13] 0 0
Ukraine
State/province [13] 0 0
Uzhgorod

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00319254