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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00319254
First received: April 24, 2006
Last updated: December 21, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Neoplasm Metastasis
Drug: SKI-606 (Bosutinib)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Of SKI-606 In Subjects With Advanced Or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) Rate [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Baseline up to Year 2 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov 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.


Enrollment: 75
Study Start Date: May 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Advanced breast cancer Drug: SKI-606 (Bosutinib)
SKI-606 (Bosutinib) 400mg once daily, for as long as tolerated or until disease progression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319254

Locations
United States, California
Pfizer Investigational Site
Duarte, California, United States, 91010-3000
Pfizer Investigational Site
Santa Monica, California, United States, 90404
United States, Florida
Pfizer Investigational Site
Tampa, Florida, United States, 33612
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
Australia, New South Wales
Pfizer Investigational Site
Darlinghurst, New South Wales, Australia, 2010
France
Pfizer Investigational Site
Dijon, France, 21034
Pfizer Investigational Site
Saint-Herblain, France, 44805
Hong Kong
Pfizer Investigational Site
Pokfulam, Hong Kong
Malta
Pfizer Investigational Site
Floriana, Malta, VLT 14
Poland
Pfizer Investigational Site
Lodz, Poland, 90-553
Pfizer Investigational Site
Wroclaw, Poland, 51-124
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 115478
Ukraine
Pfizer Investigational Site
Dnipropetrovsk, Ukraine, 49102
Pfizer Investigational Site
Sumy, Ukraine, 40005
Pfizer Investigational Site
Uzhgorod, Ukraine, 88014
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00319254     History of Changes
Other Study ID Numbers: 3160A2-201, B1871014
Study First Received: April 24, 2006
Results First Received: October 4, 2012
Last Updated: December 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Advanced Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014