Breast NeoplasmsPhase 2NCT00319254
Study Evaluating SKI-606 (Bosutinib) In Subjects With Breast Cancer
A Phase 2 study testing SKI-606 (Bosutinib) in people with Breast Neoplasms and Neoplasm Metastasis, run by Pfizer at 15 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Neoplasm Metastasis
- What is being tested?
- SKI-606 (Bosutinib)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 15 sitesin 8 countries
- Study dates
- May 2006to Feb 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
15 sites in 8 countries.
15 sites in 8 countries
United States4 sites
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Duarte, California, 91010-3000
Pfizer Investigational Site
Santa Monica, California, 90404
Pfizer Investigational Site
Tampa, Florida, 33612
Ukraine3 sites
Pfizer Investigational Site
Dnipropetrovsk, 49102
Pfizer Investigational Site
Sumy, Ukraine, 40005
Pfizer Investigational Site
Uzhhorod, 88014
France2 sites
Pfizer Investigational Site
Dijon, 21034
Pfizer Investigational Site
Saint-Herblain, 44805
Poland2 sites
Pfizer Investigational Site
Lodz, 90-553
Pfizer Investigational Site
Wroclaw, 51-124
Australia1 site
Pfizer Investigational Site
Darlinghurst, New South Wales, 2010
About this study
Official title: Phase II Study Of SKI-606 In Subjects With Advanced Or Metastatic Breast Cancer
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.
- Conditions
- Breast Neoplasms, Neoplasm Metastasis
- Being tested
- SKI-606 (Bosutinib)
- Keywords
- Advanced Breast Cancer
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKI-606 (Bosutinib)Drug
SKI-606 (Bosutinib) 400mg once daily, for as long as tolerated or until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Advanced breast cancer | Experimental | Not described Receives: Drug: SKI-606 (Bosutinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to Week 16
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.
Measured: Baseline up to 30 days after last dose of study treatment
Secondary outcomes (8)
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.
Measured: Baseline up to Year 2
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.
Measured: Baseline up to Year 1
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.
Measured: Baseline up to end of treatment (Week 77)
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.
Measured: Baseline up to end of treatment (Week 77)
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.
Measured: Baseline up to end of treatment (Week 77)
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.
Measured: Baseline up to end of treatment (Week 77)
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.
Measured: Day 1 up to end of treatment (Week 77)
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.
Measured: Baseline, Weeks 1,4,8,12,16, every 8 weeks thereafter and 14 days after last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startMay 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319254
- Sponsor's protocol ID
- 3160A2-201
- Other IDs
- B1871014
- Status last verified
- Dec 2012
- First submitted
- 24 Apr 2006
- Last updated
- 31 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Of SKI-606 In Subjects With Advanced Or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00319254
- Acronym / sponsor ID
- 3160A2-201
- Conditions
- Breast Neoplasms, Neoplasm Metastasis
- Keywords
- Advanced Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 27 Apr 2006 (estimated)
- Results
- Posted 31 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced breast cancer | Experimental | Drug: SKI-606 (Bosutinib) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SKI-606 (Bosutinib)SKI-606 (Bosutinib) 400mg once daily, for as long as tolerated or until disease progression. | Drug | Advanced breast cancer |
Primary outcome
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.
8 secondary outcomes
Overall Survival (OS)
Time frame: Baseline up to Year 2
Percentage of Participants With Objective Response (OR)
Time frame: Baseline up to Year 1
Percentage of Participants With Clinical Benefit
Time frame: Baseline up to end of treatment (Week 77)
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 Change From Baseline in Electrocardiogram (ECG)
Time frame: Baseline up to end of treatment (Week 77)
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)
Concomitant Medications Used for Management of Adverse Events (AEs)
Time frame: Day 1 up to end of treatment (Week 77)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
15 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SKI-606 (Bosutinib) in people with Breast Neoplasms and Neoplasm Metastasis, run by Pfizer at 15 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Ukraine, France, Poland, Australia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) Rate (time frame: Baseline up to Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2013.