Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| B1871014 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced breast cancer | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKI-606 (Bosutinib) | Drug | SKI-606 (Bosutinib) 400mg once daily, for as long as tolerated or until disease progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline up to 30 days after last dose of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to Year 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Population Pharmacokinetics (PK) | 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. | 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Duarte | California | 91010-3000 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Bosutinib | Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bosutinib | Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-To-Treat (ITT) population included all enrolled participants who received at least 1 dose of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Week 16 |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bosutinib | Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C471992 | bosutinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | Baseline, Weeks 1,4,8,12,16, every 8 weeks thereafter and 14 days after last dose of study treatment |
| Santa Monica |
| California |
| 90404 |
| United States |
| Pfizer Investigational Site | Tampa | Florida | 33612 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44195 | United States |
| Pfizer Investigational Site | Darlinghurst | New South Wales | 2010 | Australia |
| Pfizer Investigational Site | Dijon | 21034 | France |
| Pfizer Investigational Site | Saint-Herblain | 44805 | France |
| Pfizer Investigational Site | Pokfulam | Hong Kong |
| Pfizer Investigational Site | Floriana | VLT 14 | Malta |
| Pfizer Investigational Site | Lodz | 90-553 | Poland |
| Pfizer Investigational Site | Wroclaw | 51-124 | Poland |
| Pfizer Investigational Site | Moscow | 115478 | Russia |
| Pfizer Investigational Site | Sumy | Ukraine | 40005 | Ukraine |
| Pfizer Investigational Site | Dnipropetrovsk | 49102 | Ukraine |
| Pfizer Investigational Site | Uzhhorod | 88014 | Ukraine |
| Enrolled, Not Treated |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | 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. | Safety population included all enrolled participants who received at least 1 dose of study treatment. | Posted | Number | percentage of participants | Baseline up to 30 days after last dose of study treatment |
|
|
|
| Secondary | 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. | ITT population included all enrolled participants who received at least 1 dose of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Year 2 |
|
|
|
| Secondary | 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. | ITT population included all enrolled participants who received at least 1 dose of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Year 1 |
|
|
|
| Secondary | 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. | ITT population included all enrolled participants who received at least 1 dose of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to end of treatment (Week 77) |
|
|
|
| Secondary | 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. | Safety population included all enrolled participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) represents number of participants who had at least 1 on-treatment assessment. | Posted | Number | participants | Baseline up to end of treatment (Week 77) |
|
|
|
| Secondary | 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. | Safety population included all enrolled participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) represents number of participants who had at least 1 on-treatment assessment. | Posted | Number | participants | Baseline up to end of treatment (Week 77) |
|
|
|
| Secondary | 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. | Safety population included all enrolled participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) represents number of participants who had at least 1 on-treatment assessment. | Posted | Number | participants | Baseline up to end of treatment (Week 77) |
|
|
|
| Secondary | 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. | Data for this pre-specified outcome measure was not statistically summarized for analysis, but collected and reported in individual participant listings as planned. | Posted | Day 1 up to end of treatment (Week 77) |
|
|
| Secondary | 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. | Data for this pre-specified outcome was collected but not statistically summarized for analysis as there were no clinically significant changes observed. | Posted | Baseline, Weeks 1,4,8,12,16, every 8 weeks thereafter and 14 days after last dose of study treatment |
|
|
| Other Pre-specified | Population Pharmacokinetics (PK) | 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. | Not Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | 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 |
| 24 |
| 73 |
| 70 |
| 73 |
| Ileus | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA | Non-systematic Assessment |
|
| Performance status decreased | General disorders | MedDRA | Non-systematic Assessment |
|
| Cytolytic hepatitis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Non-systematic Assessment |
|
| Malaise | Investigations | MedDRA | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D017437 |
| Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Total Bilirubin (>3*ULN) |
|
| ALT (>5*ULN) |
|
| AST (>5*ULN) |
|
| Lipase (>2*ULN) |
|
| Neutrophils (<1*10^9/L) |
|
| Title | Measurements |
|---|---|
|
| Overall ECG not normal |
|
| Title | Measurements |
|---|---|
|
| Ophthalmological examinations |
|