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Trial record 18 of 23 for:    Pancreatic Cancer | ( Map: Hong Kong )

Study Of Bosutinib With Capecitabine In Solid Tumors And Locally Advanced Or Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00959946
Recruitment Status : Terminated
First Posted : August 17, 2009
Results First Posted : February 22, 2013
Last Update Posted : February 22, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Advanced Breast Cancer (Parts 1 and 2)
Advanced Pancreatic Cancer (Part 1)
Advanced Colorectal Cancer (Part 1)
Advanced Cholangiocarcinoma (Part 1)
Advanced Glioblastoma Multiforme (Part 1)
Interventions Drug: Bosutinib
Drug: Capecitabine
Enrollment 32
Recruitment Details  
Pre-assignment Details Study was pre-maturely terminated after part 1 (safety lead-in phase) of study and hence, planned treatments of part 2, Bosutinib 300 milligram (mg) + Capecitabine 1000 mg/square meter (mg/m^2) (Part 2): estrogen receptor positive (ER+) and Bosutinib 300 mg+Capecitabine 1000 mg/m^2 (Part 2): estrogen receptor negative (ER-), were not administered.
Arm/Group Title Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1) Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1) Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)
Hide Arm/Group Description Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent. Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent. Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent. Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent. Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent. Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent. Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent. Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
Period Title: Overall Study
Started 2 4 4 5 4 9 2 2
Completed 0 0 0 0 0 0 0 0
Not Completed 2 4 4 5 4 9 2 2
Reason Not Completed
Adverse Event             0             0             2             1             0             1             0             0
Death             0             0             0             0             0             1             0             0
Disease Progression             2             4             2             4             4             6             2             2
Withdrawal by Subject             0             0             0             0             0             1             0             0
Arm/Group Title Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1) Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1) Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1) Total
Hide Arm/Group Description Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent. Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent. Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent. Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent. Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent. Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent. Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent. Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent. Total of all reporting groups
Overall Number of Baseline Participants 2 4 4 5 4 9 2 2 32
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 4 participants 4 participants 5 participants 4 participants 9 participants 2 participants 2 participants 32 participants
53.0  (4.24) 56.8  (16.32) 67.3  (10.05) 63.0  (8.43) 56.0  (8.45) 63.8  (5.49) 51.5  (6.36) 61.5  (4.95) 60.7  (9.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 4 participants 4 participants 5 participants 4 participants 9 participants 2 participants 2 participants 32 participants
Female
2
 100.0%
1
  25.0%
2
  50.0%
4
  80.0%
3
  75.0%
4
  44.4%
1
  50.0%
1
  50.0%
18
  56.3%
Male
0
   0.0%
3
  75.0%
2
  50.0%
1
  20.0%
1
  25.0%
5
  55.6%
1
  50.0%
1
  50.0%
14
  43.8%
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) - Part 1
Hide Description The MTD contour is defined as the dose combinations that achieve a toxicity rate (dose-limiting toxicity [DLT] rate) of less than (<) 1/3. The observed toxicity rates for all the reporting groups (to which at least 1 cohort of participants was allocated) was estimated by calculating the proportion of DLTs observed in the first 21 days of treatment at those reporting groups. DLT includes grade (Gr) 3/4 nausea, vomiting, diarrhea, or asthenia more than 3 days, Gr 4 hematologic toxicities, delayed study treatment administration due to dose toxicities by more than 3 weeks. Pre-defined criterion for MTD: if a higher dose level of capecitabine existed such that the same dose level of bosutinib had a DLT rate of <1/3, no MTD was recommended for that capecitabine dose and if even the lowest dose of bosutinib achieved a toxicity rate of greater than (>) 1/3, no MTD was recommended for that capecitabine dose level.
Time Frame Part 1 Baseline up to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
DLT evaluable population included all participants who received at least 14 doses of bosutinib and at least 10 doses of capecitabine in the first 21 days of treatment or had experienced a DLT within the first 21 days of treatment. N (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title Bosutinib + Capecitabine 625 mg/m^2 Bosutinib + Capecitabine 750 mg/m^2 Bosutinib + Capecitabine 1000 mg/m^2
Hide Arm/Group Description:
Bosutinib 200 mg, or 300 mg, tablet administered orally once daily in a 21-day cycle. Capecitabine 625 mg/m^2 tablet administered orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
Bosutinib 200 mg, 300 mg, or 400 mg tablet administered orally once daily in a 21-day cycle. Capecitabine 750 mg/m^2 tablet administered orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
Bosutinib 200 mg, 300 mg, or 400 mg tablet administered orally once daily in a 21-day cycle. Capecitabine 1000 mg/m^2 tablet administered orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 6 10 8
Measure Type: Number
Unit of Measure: mg
NA [1]  NA [2]  300
[1]
MTD was not achieved since none of the participants experienced dose-limiting toxicity.
[2]
Bosutinib 400 mg + Capecitabine 750 mg/m^2 had DLT >1/3, and both Bosutinib 300 mg + Capecitabine 1000 mg/m^2 and Bosutinib 300 mg + Capecitabine 750 mg/m^2 had DLT <1/3, hence no MTD for Capecitabine 750 mg/m^2 as per pre-defined criterion.
2.Primary Outcome
Title Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) - Part 1
Hide 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 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Part 1 Baseline up to 28 days after last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: included participants who received at least 1 dose of the study medication.
Arm/Group Title Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1) Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1) Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)
Hide Arm/Group Description:
Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 2 4 4 5 4 9 2 2
Measure Type: Number
Unit of Measure: Percentage of Participants
AEs 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
SAEs 0.0 50.0 50.0 40.0 0.0 33.3 0.0 50.0
3.Primary Outcome
Title Percentage of Participants With Objective Response - Part 2
Hide Description Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.0). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR is defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions (LDs) of the target lesions taking as a reference the baseline sum LDs.
Time Frame Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.
Arm/Group Title Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+ Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-
Hide Arm/Group Description:
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Best Overall Response - Part 1
Hide Description Best overall response based on investigator's disease status assessment. CR: disappearance of all lesions. PR: at least 30% decrease in sum of LDs of target lesions taking as reference baseline sum LDs. Progressive disease (PD): at least 20% increase in sum of LD of target lesions taking as a reference smallest sum of the recorded LDs since treatment start, or the appearance of 1 or more new lesions. Stable disease (SD): neither sufficient shrinkage for PR nor sufficient increase for PD taking as reference smallest sum of LD since treatment started.
Time Frame Part 1 Baseline, every 6 weeks up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population included participants who received at least 14 doses of bosutinib and at least 10 doses of capecitabine within a 21-day period, had a baseline and at least 1 post-baseline tumor assessment, and had no major protocol violations.
Arm/Group Title Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1) Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1) Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)
Hide Arm/Group Description:
Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 1 4 4 5 4 9 2 1
Measure Type: Number
Unit of Measure: Participants
Complete Response 0 0 0 0 0 0 0 0
Partial Response 0 0 0 0 2 0 0 0
Stable Disease 0 1 2 0 1 6 1 1
Progressive Disease 1 3 2 5 1 2 1 0
Indeterminate 0 0 0 0 0 1 0 0
5.Secondary Outcome
Title Progression Free Survival (PFS) - Part 2
Hide Description Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD), or from adverse event (AE) data (where the outcome was "Death").
Time Frame Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.
Arm/Group Title Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+ Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-
Hide Arm/Group Description:
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Clinical Benefit Rate - Part 2
Hide Description Percent of participants with confirmed CR, PR or SD for at least 24 weeks on study according to RECIST. CR: disappearance of all lesions. PR: at least 30% decrease in sum of LDs of target lesions taking as reference baseline sum LDs. SD: neither sufficient shrinkage for PR nor sufficient increase for PD taking as reference smallest sum of LD since treatment started.
Time Frame Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.
Arm/Group Title Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+ Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-
Hide Arm/Group Description:
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Duration of Response (DR) - Part 2
Time Frame Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.
Arm/Group Title Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+ Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-
Hide Arm/Group Description:
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) - Part 2
Hide Description [Not Specified]
Time Frame 0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.
Arm/Group Title Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+ Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-
Hide Arm/Group Description:
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 2
Hide Description [Not Specified]
Time Frame 0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.
Arm/Group Title Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+ Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-
Hide Arm/Group Description:
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Apparent Volume of Distribution (Vz/F) - Part 2
Hide Description Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Time Frame 0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.
Arm/Group Title Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+ Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-
Hide Arm/Group Description:
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] - Part 2
Hide Description AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).
Time Frame 0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.
Arm/Group Title Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+ Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-
Hide Arm/Group Description:
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Apparent Oral Clearance (CL/F) - Part 2
Hide Description Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time Frame 0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.
Arm/Group Title Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+ Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-
Hide Arm/Group Description:
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Terminal-Phase Disposition Rate Constant (λz) - Part 2
Hide Description The terminal-phase disposition rate constant measured by a log-linear regression of the terminal mono exponential portion of the observed plasma concentrations.
Time Frame 0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.
Arm/Group Title Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+ Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-
Hide Arm/Group Description:
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Plasma Decay Half-Life (t1/2) - Part 2
Hide Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-life was to be calculated as 0.693/λz.
Time Frame 0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.
Arm/Group Title Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+ Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-
Hide Arm/Group Description:
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1) Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1) Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)
Hide Arm/Group Description Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent. Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent. Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent. Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent. Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent. Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent. Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent. Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
All-Cause Mortality
Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1) Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1) Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1) Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1) Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   2/4 (50.00%)   2/4 (50.00%)   2/5 (40.00%)   0/4 (0.00%)   3/9 (33.33%)   0/2 (0.00%)   1/2 (50.00%) 
Blood and lymphatic system disorders                 
Anaemia * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Cardiac disorders                 
Atrial fibrillation * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  1/2 (50.00%) 
Gastrointestinal disorders                 
Gastrointestinal obstruction * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/2 (0.00%) 
General disorders                 
Asthenia * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Chest pain * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  1/2 (50.00%) 
Infections and infestations                 
Bronchitis * 1  0/2 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/2 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Glioblastoma multiforme * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/2 (0.00%) 
Neoplasm malignant * 1  0/2 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/2 (0.00%) 
Pancreatic carcinoma * 1  0/2 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Nervous system disorders                 
Hemiparesis * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Renal and urinary disorders                 
Renal impairment * 1  0/2 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Acute respiratory distress syndrome * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/2 (0.00%) 
Dyspnoea * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  1/2 (50.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1) Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1) Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1) Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/2 (100.00%)   4/4 (100.00%)   3/4 (75.00%)   5/5 (100.00%)   4/4 (100.00%)   9/9 (100.00%)   2/2 (100.00%)   2/2 (100.00%) 
Blood and lymphatic system disorders                 
Lymphopenia * 1  1/2 (50.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/2 (0.00%) 
Gastrointestinal disorders                 
Abdominal pain * 1  1/2 (50.00%)  0/4 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  3/9 (33.33%)  0/2 (0.00%)  1/2 (50.00%) 
Abdominal pain upper * 1  1/2 (50.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/4 (50.00%)  0/9 (0.00%)  1/2 (50.00%)  0/2 (0.00%) 
Constipation * 1  0/2 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/2 (0.00%) 
Diarrhoea * 1  2/2 (100.00%)  1/4 (25.00%)  2/4 (50.00%)  3/5 (60.00%)  3/4 (75.00%)  8/9 (88.89%)  2/2 (100.00%)  2/2 (100.00%) 
Flatulence * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  1/9 (11.11%)  0/2 (0.00%)  0/2 (0.00%) 
Gastrooesophageal reflux disease * 1  1/2 (50.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/9 (0.00%)  1/2 (50.00%)  0/2 (0.00%) 
Nausea * 1  0/2 (0.00%)  4/4 (100.00%)  2/4 (50.00%)  2/5 (40.00%)  1/4 (25.00%)  4/9 (44.44%)  0/2 (0.00%)  1/2 (50.00%) 
Vomiting * 1  0/2 (0.00%)  3/4 (75.00%)  1/4 (25.00%)  0/5 (0.00%)  1/4 (25.00%)  2/9 (22.22%)  2/2 (100.00%)  0/2 (0.00%) 
General disorders                 
Asthenia * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/2 (0.00%) 
Fatigue * 1  0/2 (0.00%)  2/4 (50.00%)  1/4 (25.00%)  3/5 (60.00%)  1/4 (25.00%)  5/9 (55.56%)  0/2 (0.00%)  0/2 (0.00%) 
Mucosal inflammation * 1  1/2 (50.00%)  0/4 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  2/9 (22.22%)  0/2 (0.00%)  0/2 (0.00%) 
Oedema peripheral * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  1/2 (50.00%) 
Pyrexia * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  1/4 (25.00%)  0/9 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Infections and infestations                 
Bronchitis * 1  0/2 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  1/4 (25.00%)  0/9 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Urinary tract infection * 1  1/2 (50.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  1/2 (50.00%) 
Investigations                 
Alanine aminotransferase increased * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  2/9 (22.22%)  0/2 (0.00%)  1/2 (50.00%) 
Aspartate aminotransferase increased * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  2/9 (22.22%)  0/2 (0.00%)  0/2 (0.00%) 
Electrocardiogram QT prolonged * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/4 (50.00%)  0/9 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Weight decreased * 1  0/2 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  0/9 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Metabolism and nutrition disorders                 
Decreased appetite * 1  0/2 (0.00%)  2/4 (50.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  3/9 (33.33%)  0/2 (0.00%)  1/2 (50.00%) 
Hypophosphataemia * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Arthralgia * 1  0/2 (0.00%)  0/4 (0.00%)  2/4 (50.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Back pain * 1  1/2 (50.00%)  1/4 (25.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Musculoskeletal pain * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  2/9 (22.22%)  0/2 (0.00%)  0/2 (0.00%) 
Pain in extremity * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/9 (0.00%)  1/2 (50.00%)  0/2 (0.00%) 
Nervous system disorders                 
Dizziness * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  2/5 (40.00%)  0/4 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/2 (0.00%) 
Headache * 1  0/2 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  2/9 (22.22%)  0/2 (0.00%)  0/2 (0.00%) 
Neuropathy peripheral * 1  0/2 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Peripheral sensory neuropathy * 1  1/2 (50.00%)  2/4 (50.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Psychiatric disorders                 
Depression * 1  0/2 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/2 (0.00%) 
Insomnia * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  1/9 (11.11%)  1/2 (50.00%)  0/2 (0.00%) 
Renal and urinary disorders                 
Urinary incontinence * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  2/9 (22.22%)  0/2 (0.00%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Cough * 1  1/2 (50.00%)  0/4 (0.00%)  1/4 (25.00%)  1/5 (20.00%)  0/4 (0.00%)  2/9 (22.22%)  1/2 (50.00%)  0/2 (0.00%) 
Dyspnoea * 1  0/2 (0.00%)  2/4 (50.00%)  0/4 (0.00%)  1/5 (20.00%)  1/4 (25.00%)  1/9 (11.11%)  1/2 (50.00%)  0/2 (0.00%) 
Skin and subcutaneous tissue disorders                 
Dry skin * 1  1/2 (50.00%)  0/4 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Erythema * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/9 (11.11%)  1/2 (50.00%)  0/2 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  1/2 (50.00%)  1/4 (25.00%)  2/4 (50.00%)  0/5 (0.00%)  1/4 (25.00%)  3/9 (33.33%)  1/2 (50.00%)  1/2 (50.00%) 
Pruritus * 1  1/2 (50.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  1/2 (50.00%) 
Rash * 1  0/2 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  1/2 (50.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Results are not provided because the study was terminated prior to part 2 due to unfavorable risk benefit ratio of the study treatment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00959946     History of Changes
Other Study ID Numbers: 3160A6-2208
B1871011
First Submitted: August 14, 2009
First Posted: August 17, 2009
Results First Submitted: October 4, 2012
Results First Posted: February 22, 2013
Last Update Posted: February 22, 2013