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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

SKI-606 (Bosutinib)

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring Advanced Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Advanced breast cancer

Arm Description

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) Rate

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)

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)

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)

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

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

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)

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

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)

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

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.

Full Information

NCT ID

NCT00319254

First Posted

April 24, 2006

Last Updated

December 21, 2012

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00319254

Brief Title

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

Official Title

Phase II Study Of SKI-606 In Subjects With Advanced Or Metastatic Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasms, Neoplasm Metastasis

Keywords

Advanced Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Advanced breast cancer

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

SKI-606 (Bosutinib)

Intervention Description

SKI-606 (Bosutinib) 400mg once daily, for as long as tolerated or until disease progression.

Primary Outcome Measure Information:

Title

Progression-Free Survival (PFS) Rate

Description

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.

Time Frame

Baseline up to Week 16

Title

Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)

Description

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.

Time Frame

Baseline up to 30 days after last dose of study treatment

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

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.

Time Frame

Baseline up to Year 2

Title

Percentage of Participants With Objective Response (OR)

Description

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.

Time Frame

Baseline up to Year 1

Title

Percentage of Participants With Clinical Benefit

Description

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.

Time Frame

Baseline up to end of treatment (Week 77)

Title

Number of Participants With Change From Baseline in Laboratory Test Results

Description

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.

Time Frame

Baseline up to end of treatment (Week 77)

Title

Number of Participants With Change From Baseline in Electrocardiogram (ECG)

Description

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.

Time Frame

Baseline up to end of treatment (Week 77)

Title

Number of Participants With Change From Baseline in Vital Signs, Physical Examinations, and Ophthalmological Examinations

Description

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.

Time Frame

Baseline up to end of treatment (Week 77)

Title

Concomitant Medications Used for Management of Adverse Events (AEs)

Description

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.

Time Frame

Day 1 up to end of treatment (Week 77)

Title

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

Description

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.

Time Frame

Baseline, Weeks 1,4,8,12,16, every 8 weeks thereafter and 14 days after last dose of study treatment

Other Pre-specified Outcome Measures:

Title

Population Pharmacokinetics (PK)

Description

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.

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Duarte

State/Province

California

ZIP/Postal Code

91010-3000

Country

United States

Facility Name

Pfizer Investigational Site

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Pfizer Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Pfizer Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Pfizer Investigational Site

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

Pfizer Investigational Site

City

Dijon

ZIP/Postal Code

21034

Country

France

Facility Name

Pfizer Investigational Site

City

Saint-Herblain

ZIP/Postal Code

44805

Country

France

Facility Name

Pfizer Investigational Site

City

Pokfulam

Country

Hong Kong

Facility Name

Pfizer Investigational Site

City

Floriana

ZIP/Postal Code

VLT 14

Country

Malta

Facility Name

Pfizer Investigational Site

City

Lodz

ZIP/Postal Code

90-553

Country

Poland

Facility Name

Pfizer Investigational Site

City

Wroclaw

ZIP/Postal Code

51-124

Country

Poland

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Dnipropetrovsk

ZIP/Postal Code

49102

Country

Ukraine

Facility Name

Pfizer Investigational Site

City

Sumy

ZIP/Postal Code

40005

Country

Ukraine

Facility Name

Pfizer Investigational Site

City

Uzhgorod

ZIP/Postal Code

88014

Country

Ukraine

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3160A2-201&StudyName=Study%20Evaluating%20SKI-606%20In%20Subjects%20With%20Breast%20Cancer

Description

To obtain contact information for a study center near you, click here.

Breast Neoplasms, Neoplasm Metastasis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial