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Trial record 30 of 31 for:    IGFBP2

A Study of Dasatinib (BMS-354825) in Patients With Advanced 'Triple-negative' Breast Cancer

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ClinicalTrials.gov Identifier: NCT00371254
Recruitment Status : Completed
First Posted : September 4, 2006
Results First Posted : March 15, 2011
Last Update Posted : March 15, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Cancer
Metastasis
Intervention Drug: Dasatinib
Enrollment 55
Recruitment Details  
Pre-assignment Details 55 participants were enrolled in the study; 11 discontinued prior to study drug administration (8 no longer met study criteria, 2 other reasons and 1 administrative reason by the sponsor)
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions. Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Period Title: Overall Study
Started 23 [1] 21 [1]
Completed 0 [2] 0 [2]
Not Completed 23 21
Reason Not Completed
Disease progression             13             13
Study drug toxicity             3             5
Subject request             5             0
Investigator Decision             2             0
Adverse event unrelated to study drug             0             1
Lost to Follow-up             0             1
Withdrawal by Subject             0             1
[1]
Number of participants treated
[2]
Number of participants remained on study till the study drug could be tolerated
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID Total
Hide Arm/Group Description Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions. Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions. Total of all reporting groups
Overall Number of Baseline Participants 23 21 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants 21 participants 44 participants
<50 years 4 9 13
>=50 years 19 12 31
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 21 participants 44 participants
56.4  (8.98) 51.5  (9.34) 54.0  (9.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 21 participants 44 participants
Female
23
 100.0%
21
 100.0%
44
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 21 participants 44 participants
Hispanic or Latino
3
  13.0%
2
   9.5%
5
  11.4%
Not Hispanic or Latino
9
  39.1%
12
  57.1%
21
  47.7%
Unknown or Not Reported
11
  47.8%
7
  33.3%
18
  40.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants 21 participants 44 participants
White 20 19 39
Black or African American 2 1 3
Asian 0 1 1
Unknown or Not Reported 1 0 1
1.Primary Outcome
Title Number of Participants With Complete Response (CR) or Partial Response (PR)
Hide Description Tumor response was defined as the number of participants whose best response was CR or PR, per the Response Evaluation Criteria in Solid Tumor (RECIST): CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD.
Time Frame Baseline to end of study drug therapy (up to 65 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug.
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 23 20
Measure Type: Number
Unit of Measure: participants
2 0
2.Primary Outcome
Title Percentage of Participants With Complete Response (CR) or Partial Response (PR)
Hide Description The percentage of participants whose best response was CR or PR, per the RECIST: CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD.
Time Frame Baseline to end of study drug therapy (up to 65 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug were included in this dataset.
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 23 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.7
(1.07 to 28.04)
0.0
(0.0 to 0.0)
3.Secondary Outcome
Title Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study
Hide Description The number of participants whose best response was CR, PR or SD (per the RECIST) at or after 16 weeks on study: CR: disappearance of all target/non-target lesions; PR: >=30% decrease in the sum of the LDs of target lesions relative to baseline sum LD; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD: appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Time Frame Baseline to 16 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug.
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 23 20
Measure Type: Number
Unit of Measure: Participants
3 1
4.Secondary Outcome
Title Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study
Hide Description The percentage of participants whose best response was CR, PR or SD (per the RECIST) at or after 16 weeks on study: CR: disappearance of all target/non-target lesions; PR: >=30% decrease in the sum of the LDs of target lesions relative to baseline sum LD; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD: appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Time Frame Baseline to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug.
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 23 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.04
(2.78 to 33.59)
5.0
(0.13 to 24.87)
5.Secondary Outcome
Title Proportion of Participants With Progression-Free Survival (PFS) at Weeks 9, 17, and 25
Hide Description PFS:time from first dose until the date that progressive disease (PD) or clinical PD (cPD) observed,per RECIST criteria.PD:appearance of new lesion/s,or >=20% increase in the sum of the LD of target lesions,relative to smallest sum LD recorded since treatment start,or unequivocal progression of existing non-target lesions;cPD:deterioration related to disease requiring treatment discontinuation,but without radiographic PD.Participants who died without PD were considered to have PD on the date of death.For participants who neither progressed nor died,date of the last tumor assessment was used.
Time Frame Weeks 9, 17, and 25
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 23 21
Measure Type: Number
Unit of Measure: Proportion of Participants
Week 9 0.40 0.35
Week 17 0.32 0.14
Week 25 0.21 0.00
6.Secondary Outcome
Title Mean Number of Weeks of Complete Response (CR) or Partial Response (PR)
Hide Description Mean number of weeks of CR/PR (time from first date of CR/PR until first date PD observed. Tumor response defined per RECIST: CR: disappearance of all target/non-target lesions; PR: >=30% decrease in sum of LDs of target lesions relative to baseline sum LD; PD: appearance of new lesion or >=20% increase in sum of LD of target lesions relative to smallest sum LD or unequivocal progression of existing non-target lesions. Participants who died without reported PD were considered to have PD on date of death. For participants who neither progressed nor died, date of last tumor assessment used.
Time Frame Baseline to end of study drug therapy (up to 53.86 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable participants who achieved a complete response (CR) or partial response (PR)
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 2 0
Mean (Full Range)
Unit of Measure: weeks
31
(8.14 to 53.86)
7.Secondary Outcome
Title Mean Plasma Concentration at Week 3
Hide Description Mean plasma concentration was obtained directly from the concentration-time data.
Time Frame At pre-dose and 1, 3, 6 and 12 hours after each dose administration
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were evaluable for pharmacokinetic analysis. "n" signifies the number of participants evaluable at each time point.
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID Dasatinib 50 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 50 mg dasatinib tablet twice daily for a total daily dose (TDD) of 100 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 10 10 1
Mean (Standard Deviation)
Unit of Measure: nanograms (ng)/mL
0 hour (n = 10, 10, 1) 9.02  (3.79) 7.14  (4.41) 2.88 [1]   (NA)
1 hour (n = 10, 10, 1) 103.35  (80.94) 66.41  (47.53) 35.05 [1]   (NA)
3 hour (n = 10, 10, 1) 50.98  (35.23) 35.47  (21.51) 32.58 [1]   (NA)
6 hour (n = 10, 10, 1) 19.02  (8.43) 14.28  (8.78) 10.35 [1]   (NA)
12 hour (n = 7, 6, 1) 9.11  (3.39) 15.43  (17.60) 3.60 [1]   (NA)
[1]
Number of participants too small.
8.Secondary Outcome
Title Mean Plasma Concentration at Week 7
Hide Description Mean plasma concentration was obtained directly from the concentration-time data.
Time Frame At pre-dose and 1, 3, 6 and 12 hours after each dose administration
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were evaluable for pharmacokinetic analysis. "n" signifies the number of participants evaluable at each time point.
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: nanograms (ng)/mL
0 hour (n = 2, 6) 8.87  (0.49) 4.89  (2.16)
1 hour (n = 2, 6) 120.92  (23.16) 84.36  (62.01)
3 hour (n = 3, 6) 37.04  (2.26) 44.80  (12.40)
6 hour (n = 2, 6) 15.75  (0.14) 14.25  (4.69)
12 hour (n = 1, 5) 8.39 [1]   (NA) 18.87  (30.11)
[1]
Number of participants too small.
9.Secondary Outcome
Title Mean Change in Concentration of Collagen Type IV From Baseline
Hide Description Collagen Type IV is a measure of anti-angiogenic activity. Plasma samples for assessment of change in concentration of Collagen Type IV were obtained and analyzed by enzyme-linked immunosorbent assay.
Time Frame Baseline, Week 3 and Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were evaluable for pharmacodynamic analysis.
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 23 20
Geometric Mean (90% Confidence Interval)
Unit of Measure: percentage of baseline
Week 3 (n = 17, 12)
39.51
(28.60 to 51.34)
26.92
(12.06 to 43.76)
Week 5 (n = 8, 11)
34.31
(17.46 to 53.58)
35.18
(15.80 to 57.82)
10.Secondary Outcome
Title Mean Change in Concentration of Vascular Endothelial Growth Factor Receptor-2 (VEGFR2) From Baseline
Hide Description VEGFR2 is a measure of anti-angiogenic activity. Plasma samples for assessment of change in concentration of VEGFR2 were obtained and analyzed by enzyme-linked immunosorbent assay.
Time Frame Baseline, Week 3 and Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were evaluable for pharmacodynamic analysis.
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 23 20
Geometric Mean (90% Confidence Interval)
Unit of Measure: percentage of baseline
Week 3 (n = 17, 12)
25.07
(17.73 to 32.86)
18.59
(13.12 to 24.32)
Week 5 (n = 8, 11)
33.56
(22.23 to 45.94)
25.12
(17.59 to 33.12)
11.Secondary Outcome
Title Percentage Change in Tumor Biomarkers
Hide Description Tumor markers are indicators of tumor activity which may be used to predict clinical benefit and circulating biomarkers may reveal key mechanisms of action. Tissue staining was performed for caveolin, phospho-caveolin, EphA2 and insulin-like growth factor binding protein 2 (IGFBP2) markers using immunohistochemistry assays.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who were evaluable for the analysis. These data for tumor markers were integrated with those from other studies and are not reportable for this study alone.
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Profiling of Messenger-ribonucleic Acid (mRNA) Expression: mRNA Signal Intensity
Hide Description Pharmacogenomic analysis included the assessment of the relationship between clinical benefit and mRNA expression levels and between clinical benefit and protein phosphorylation. Tumor mRNA expression was analyzed in all available tissues. mRNA was extracted from 96 formalin-fixed paraffin-embedded tissue (FFPET) samples, amplified, and fluorescently labeled. Gene expression profiling was conducted using Affymetrix Human Genome U133A 2.0 DNA microarrays. mRNA expression is reported as quantile normalized RMA values.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who were evaluable for the analysis. These data for pharmacogenomic analyses were integrated with those from other studies and are not reportable for this study alone.
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs) or Adverse Events (AEs)
Hide Description An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). An SAE was defined as an AE that resulted in death, was life-threatening, required hospitalization (or prolongation of existing hospitalization), or was an important medical event.
Time Frame From start of study drug therapy up to 30 days after the last dose.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants.
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 23 21
Measure Type: Number
Unit of Measure: participants
Death 1 0
Serious adverse events (SAEs) 11 3
All adverse events (AEs) 23 21
14.Secondary Outcome
Title Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3 AEs and Discontinuations Due to Drug-related AEs
Hide Description AE=any new untoward medical occurrence/worsening of pre-existing medical condition.SAE=AE that resulted in death, was life-threatening, required hospitalization (or prolongation of existing hospitalization), or was an important medical event. Drug-related SAEs or AEs are those events with relationship to study therapy of certain, probable or possible.AEs were graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), v3: Grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death.Participants who discontinued the study due to any drug-related AEs were also recorded.
Time Frame From start of study drug therapy up to 30 days after the last dose.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 23 21
Measure Type: Number
Unit of Measure: participants
Drug-related SAEs 5 1
Drug-related AEs 23 19
Drug-related Grade 3 AEs 12 8
Drug-related AEs Leading to Discontinuation 4 6
15.Secondary Outcome
Title Most Frequent Drug-related Adverse Events (AEs)
Hide Description Most frequent drug-related AEs are those AEs with frequency >=25% in either group. Drug-related AEs are those events with relationship to study therapy of certain, probable or possible.
Time Frame From start of study drug therapy up to 30 days after the last dose.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 23 21
Measure Type: Number
Unit of Measure: participants
Diarrhea 12 7
Fatigue 10 14
Nausea 10 14
Dyspnea 10 6
Pleural Effusion 9 7
Rash 9 5
Headache 8 4
Anorexia 9 0
Vomiting 7 6
Cough 7 5
Abdominal pain 7 0
16.Secondary Outcome
Title Number of Participants With Grade 3 or 4 Abnormalities in Hematology Measurements
Hide Description Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. Grades 3 and 4 criteria are defined as follows: Granulocytes: Grade 3 <1.0 - 0.5 x 10^9/L; Grade 4, <0.5 x 10^9/L. Hemoglobin: Grade 3, <8.0 - 6.5 g/dL; Grade 4, <6.5 g/dL. Platelets: Grade 3, <50.0 - 25.0 x 10^9/L; Grade 4, <25.0 x 10^9/L. Leukocytes: Grade 3, <2.0 - 1.0 x 10^9/L; Grade 4, <1.0 x 10^9/L.
Time Frame Throughout study, from start of study drug therapy up to 30 days after the last dose.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 23 21
Measure Type: Number
Unit of Measure: participants
Granulocytes 3 0
Hemoglobin 0 0
Platelet Count 0 0
Leukocytes 0 0
17.Secondary Outcome
Title Number of Participants With Abnormalities (Grade 1 or 2) in Prothrombin Time (PT)
Hide Description PT is a measure of the clotting ability of the blood. Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and 5=death.
Time Frame Throughout study, from start of study drug therapy up to 30 days after the last dose.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 23 21
Measure Type: Number
Unit of Measure: participants
Grade 1 3 0
Grade 2 0 0
18.Secondary Outcome
Title Number of Participants With Abnormalities (Grade 1 or 2) in Partial Thromboplastin Time (PTT)
Hide Description PTT is a measure of the clotting ability of the blood. Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and 5=death.
Time Frame Throughout study, from start of study drug therapy up to 30 days after the last dose.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants.
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 23 21
Measure Type: Number
Unit of Measure: Participants
0 0
19.Secondary Outcome
Title Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase
Hide Description Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. Grade 3 and 4 criteria are defined as follows: ALT, AST and alkaline phosphatase: Grade 3: >5-20 x upper limit of normal (ULN), Grade 4: >20 x ULN.
Time Frame Throughout study, from start of study drug therapy up to 30 days after the last dose.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 23 21
Measure Type: Number
Unit of Measure: participants
Alkaline phosphatase 1 1
Alanine aminotransferase 1 3
Aspartate aminotransferase 0 3
20.Secondary Outcome
Title Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Calcium, Potassium, Magnesium and Sodium
Hide Description Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. Grade 3 and 4 criteria are defined as follows: Calcium: Grade 3-4 : <6.0 – <7.0 or >12.5 – >13.5 mg/dL, Potassium: Grade 3-4 : <2.5 – <3.0 or >6.0 – >7.0 mEq/L, Magnesium: Grade 3-4 : <0.6 - <0.8 or >2.46 - >6.6 mEq/L, Sodium:< 120– 130 or >155 – >160 mEq/L.
Time Frame Throughout study, from start of study drug therapy up to 30 days after the last dose.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 23 21
Measure Type: Number
Unit of Measure: participants
High calcium 0 0
Low calcium 0 1
High potassium 0 0
Low potassium 1 0
High magnesium 0 0
Low magnesium 0 0
High sodium 0 0
Low sodium 0 0
21.Secondary Outcome
Title Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Creatinine, Bicarbonate, Inorganic Phosphorous and Bilirubin (Total).
Hide Description Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. Grade 3 and 4 criteria are defined as follows: Creatinine: Grade 3-4 : > 3.0 -6.0 ULN (upper limit of normal),Bicarbonate: Grade 3-4: <16 -<22 mEq/L, Phosphorous: Grade 3-4 : <1.0 - <2.0 mg/dL, Bilirubin, total: Grade 3-4: >3.0 - >10.0 ULN.
Time Frame Throughout study, from start of study drug therapy up to 30 days after the last dose.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 23 21
Measure Type: Number
Unit of Measure: participants
Creatinine 0 0
Bicarbonate 0 0
Inorganic Phosphorus 1 2
Bilirubin, Total 0 0
22.Secondary Outcome
Title Number of Participants With Identified Electrocardiogram (ECG) Abnormalities
Hide Description ECGs were performed and all recordings were evaluated by the investigator. Abnormalities, if present at any study time point, were listed. The following ECG variables were collected: heart rate, PR interval, QRS width, and QT interval. Abnormalities in ECGs were defined by reference to institutional reports.
Time Frame Baseline, Weeks 3, 9, 17 and 25, then every 8 weeks until the end of study treatment (up to 17 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 23 21
Measure Type: Number
Unit of Measure: participants
4 3
23.Secondary Outcome
Title Number of Participants With Abnormal Vital Signs Measurements
Hide Description Vital signs included systolic and diastolic blood pressure and heart rate. The investigator used his or her judgement to decide whether or not the values were abnormal.
Time Frame At each study visit (Week 3, 5, 7, 9, 13, 17 and 25) and end of treatment (up to 17 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Dasatinib 100 mg BID Dasatinib 70 mg BID
Hide Arm/Group Description:
Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Number of Participants Analyzed 23 21
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Participants
Hide Arm/Group Description All treated participants who were administered a twice-daily oral dose of either 100 mg (TDD 200 mg) or 70 mg (TDD 140 mg) dasatinib tablet. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   14/44 (31.82%) 
Cardiac disorders   
MYOPERICARDITIS  1  1/44 (2.27%) 
PERICARDIAL EFFUSION  1  2/44 (4.55%) 
Gastrointestinal disorders   
NAUSEA  1  1/44 (2.27%) 
ASCITES  1  1/44 (2.27%) 
VOMITING  1  2/44 (4.55%) 
DYSPHAGIA  1  1/44 (2.27%) 
CONSTIPATION  1  1/44 (2.27%) 
ABDOMINAL PAIN  1  1/44 (2.27%) 
General disorders   
PYREXIA  1  2/44 (4.55%) 
GENERALISED OEDEMA  1  1/44 (2.27%) 
GENERAL PHYSICAL HEALTH DETERIORATION  1  1/44 (2.27%) 
Infections and infestations   
INFECTION  1  1/44 (2.27%) 
PNEUMONIA  1  1/44 (2.27%) 
Musculoskeletal and connective tissue disorders   
BACK PAIN  1  1/44 (2.27%) 
COSTOCHONDRITIS  1  1/44 (2.27%) 
MUSCULOSKELETAL CHEST PAIN  1  1/44 (2.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
MALIGNANT NEOPLASM PROGRESSION  1  2/44 (4.55%) 
Renal and urinary disorders   
RENAL FAILURE ACUTE  1  1/44 (2.27%) 
Respiratory, thoracic and mediastinal disorders   
DYSPNOEA  1  3/44 (6.82%) 
HAEMOPTYSIS  1  1/44 (2.27%) 
PNEUMONITIS  1  1/44 (2.27%) 
PLEURAL EFFUSION  1  3/44 (6.82%) 
RESPIRATORY FAILURE  1  1/44 (2.27%) 
Skin and subcutaneous tissue disorders   
PERIORBITAL OEDEMA  1  1/44 (2.27%) 
Vascular disorders   
HYPOTENSION  1  2/44 (4.55%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Participants
Affected / at Risk (%)
Total   44/44 (100.00%) 
Blood and lymphatic system disorders   
ANAEMIA  1  4/44 (9.09%) 
NEUTROPENIA  1  4/44 (9.09%) 
Eye disorders   
DRY EYE  1  3/44 (6.82%) 
Gastrointestinal disorders   
NAUSEA  1  25/44 (56.82%) 
VOMITING  1  14/44 (31.82%) 
DIARRHOEA  1  20/44 (45.45%) 
DYSPEPSIA  1  3/44 (6.82%) 
STOMATITIS  1  4/44 (9.09%) 
CONSTIPATION  1  10/44 (22.73%) 
ABDOMINAL PAIN  1  8/44 (18.18%) 
ABDOMINAL DISTENSION  1  4/44 (9.09%) 
ABDOMINAL PAIN UPPER  1  3/44 (6.82%) 
General disorders   
PAIN  1  3/44 (6.82%) 
FATIGUE  1  25/44 (56.82%) 
PYREXIA  1  7/44 (15.91%) 
ASTHENIA  1  8/44 (18.18%) 
CHEST PAIN  1  3/44 (6.82%) 
Infections and infestations   
URINARY TRACT INFECTION  1  3/44 (6.82%) 
Investigations   
WEIGHT DECREASED  1  5/44 (11.36%) 
ALANINE AMINOTRANSFERASE  1  4/44 (9.09%) 
ASPARTATE AMINOTRANSFERASE  1  4/44 (9.09%) 
ELECTROCARDIOGRAM QT PROLONGED  1  3/44 (6.82%) 
Metabolism and nutrition disorders   
ANOREXIA  1  12/44 (27.27%) 
Musculoskeletal and connective tissue disorders   
MYALGIA  1  8/44 (18.18%) 
BACK PAIN  1  6/44 (13.64%) 
ARTHRALGIA  1  6/44 (13.64%) 
PAIN IN EXTREMITY  1  5/44 (11.36%) 
MUSCULOSKELETAL PAIN  1  4/44 (9.09%) 
MUSCULOSKELETAL CHEST PAIN  1  3/44 (6.82%) 
Nervous system disorders   
HEADACHE  1  15/44 (34.09%) 
DIZZINESS  1  3/44 (6.82%) 
PARAESTHESIA  1  3/44 (6.82%) 
Psychiatric disorders   
ANXIETY  1  5/44 (11.36%) 
INSOMNIA  1  7/44 (15.91%) 
Respiratory, thoracic and mediastinal disorders   
COUGH  1  17/44 (38.64%) 
DYSPNOEA  1  19/44 (43.18%) 
PLEURAL EFFUSION  1  15/44 (34.09%) 
Skin and subcutaneous tissue disorders   
RASH  1  16/44 (36.36%) 
ERYTHEMA  1  3/44 (6.82%) 
PRURITUS  1  4/44 (9.09%) 
Vascular disorders   
FLUSHING  1  4/44 (9.09%) 
HOT FLUSH  1  5/44 (11.36%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00371254     History of Changes
Other Study ID Numbers: CA180-059
First Submitted: September 1, 2006
First Posted: September 4, 2006
Results First Submitted: October 7, 2010
Results First Posted: March 15, 2011
Last Update Posted: March 15, 2011