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Study of Dasatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00439270
Collaborator
(none)
49
Enrollment
5
Locations
5
Arms
66.1
Duration (Months)
9.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to find the recommended doses of dasatinib and docetaxel given in combination to men with metastatic hormone refractory prostate cancer and to assess the pharmacokinetic interactions between the 2 drugs.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I/II Study of Dasatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer
Study Start Date :
Jul 1, 2007
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Dasatinib, 50 mg + Docetaxel, 60 mg/m^2

Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2.

Drug: Dasatinib
Tablets, Oral, 50, 70, 100, or 120 mg once daily; treatment may continue until disease progression
Other Names:
  • Sprycel
  • BMS-354825

    • Drug: Docetaxel
    Infusion, 60 or 75 mg/m^2, administered every 3 weeks.
    Active Comparator: Dasatinib, 50 mg + Doxetaxel, 75 mg/m^2

    Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.

    Drug: Dasatinib
    Tablets, Oral, 50, 70, 100, or 120 mg once daily; treatment may continue until disease progression
    Other Names:
  • Sprycel
  • BMS-354825

    • Drug: Docetaxel
    Infusion, 60 or 75 mg/m^2, administered every 3 weeks.
    Active Comparator: Dasatinib, 70 mg + Docetaxel, 75 mg/m^2

    Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.

    Drug: Dasatinib
    Tablets, Oral, 50, 70, 100, or 120 mg once daily; treatment may continue until disease progression
    Other Names:
  • Sprycel
  • BMS-354825

    • Drug: Docetaxel
    Infusion, 60 or 75 mg/m^2, administered every 3 weeks.
    Active Comparator: Dasatinib, 100 mg + Docetaxel, 75 mg/m^2

    Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.

    Drug: Dasatinib
    Tablets, Oral, 50, 70, 100, or 120 mg once daily; treatment may continue until disease progression
    Other Names:
  • Sprycel
  • BMS-354825

    • Drug: Docetaxel
    Infusion, 60 or 75 mg/m^2, administered every 3 weeks.
    Active Comparator: Dasatinib, 120 mg + Docetaxel, 75 mg/m^2

    Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.

    Drug: Dasatinib
    Tablets, Oral, 50, 70, 100, or 120 mg once daily; treatment may continue until disease progression
    Other Names:
  • Sprycel
  • BMS-354825

    • Drug: Docetaxel
    Infusion, 60 or 75 mg/m^2, administered every 3 weeks.

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Tolerated Dose (MTD) of Dasatinib Administered With Docetaxel [From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42)]

      MTD was defined by dose-limiting toxicity (DLT) criteria. DLT was defined as grade 4 neutropenia causing treatment interruption for >14 days, febrile neutropenia, grade 4 thrombocytopenia, grade 3 thrombocytopenia with a bleeding episode requiring platelet transfusion, nausea and/or vomiting despite medical intervention/prophylaxis causing treatment interruption for >14 days, grade 3-4 asthenia/fatigue, any other grade >=3 nonhematologic toxicity except alopecia or transient arthralgia/myalgia (unless unresponsive to intervention), or interruption of study drug for >14 days due to toxicity. When defined, the MTD would serve as recommended Phase 2 dose of each drug in the combination of oral dasatinib and intravenous docetaxel.

    2. Recommended Phase 2 Dose of Dasatinib Administered With Docetaxel, 75 mg/m^2 [From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42)]

      Because no dose-limiting toxicities occurred, the recommended dose of dasatinib used in Phase 2 was based on findings from ongoing studies in chronic myelogenous leukemia and experience from the previous Phase 2 study of single-agent dasatinib in chronic refractory prostate cancer. The recommended Phase 2 dose of docetaxel (75 mg/m^2) was based on the docetaxel package insert.

    Secondary Outcome Measures

    1. Percentage of Participants With a Prostate Specific Antigen (PSA) Response [At pretreatment visit, and on Day 1 of Cycles 2 through 12, then every other cycle, where investigator deems appropriate, and at end of treatment (up to 51.6 months)]

      PSA response rate is defined as a decrease of >=50% in PSA levels from baseline, sustained for at least 6 weeks and confirmed by at least 2 measurements

    2. Duration of Prostate Specific Antigen (PSA) Response [At pretreatment visit, and on Day 1 of Cycles 2 through 12, then every other cycle, where investigator deems appropriate, and at end of treatment]

      Duration of response is computed for participants with confirmed PSA response. It is measured in months from the time of the first of 2 consecutive measurements meeting the criteria for confirmed PSA response to the date of the first of 3 consecutive measurements that confirm PSA progression, the date of disease progression, or the date of death. Participants who neither progressed (PSA or disease) nor died were censored on the date of their last PSA assessment. PSA response is defined as a decrease of >=50% in PSA levels from baseline, sustained for at least 6 weeks and confirmed by at least 2 measurements. PSA progression is defined as 3 consecutive increases in PSA from baseline or nadir, each measurement at least 1 week apart. The final confirming PSA measurement had to be ≥5ng/mL higher than baseline or nadir and also represent at least a 50% increase from baseline or nadir (ie, the value is ≥1.5*baseline or nadir PSA).

    3. Number of Months of Progression-free Survival (PFS) [Patients with an event: time from first dose to disease progression or death, whichever occurs first. Patients without an event: time to last on-study PSA measurement, tumor assessment, or radionuclide bone scan assessment, whichever occurs last]

      PFS defined as time in months from the first dosing date to the date of disease progression or the date of death. Patients who neither progressed nor died were censored on the date of their last on-study prostate specific antigen (PSA) measurement, tumor assessment, or radionuclide bone scan assessment (whichever occurred last). Disease progression defined as either of the following: progression on radionuclide bone scan, death, or at least 2 of the following: tumor progression, as defined by modified Response Evaluation Criteria in Solid Tumors; PSA progression; or investigator-defined clinical progression based on physical examination, history, symptoms, and performance status.

    4. Percentage of Participants With an Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) [Pretreatment visit then every 6 weeks thereafter (up to 51.6 months)]

      Objective response rate is defined as the percentage of participants who have achieved best responses of confirmed Complete Response (CR) or Partial Response (PR) where confirmed requires repeat evaluations for a minimum of 4 weeks after the criteria for response are first met. RECIST: CR=disappearance of clinical and radiologic evidence of target lesions; PR=a 30% or greater decrease in the sum of the longest diameter (LD) of all lesions in reference to the baseline sum LD.

    5. Number of Participants by Best On-study Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) [Pretreatment visit then every 6 weeks thereafter (up to 51.6 months)]

      RECIST for target lesions: Complete Response (CR)=disappearance of clinical and radiologic evidence of target lesions. Partial Response (PR)=a 30% or greater decrease in the sum of the longest diameter (LD) of all lesions in reference to the baseline sum LD. Stable disease (SD)=neither sufficient increase to qualify for Progressive Disease (PD) nor sufficient shrinkage to qualify for PR. PD=a 20% or greater increase in the sum of LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline; unequivocal progression of nonmeasurable disease/lesions as evaluated by CT scan or MRI (not as evaluated by radionuclide bone scan) and/or new lesions are present. To qualify as SD, patients had to exhibit SD for a minimum of 18 weeks. Those with evaluations noted as SD prior to 18 weeks and discontinued were reported as no change.

    6. Number of Participants by Best On-study Bone Scan Assessment From Baseline [From Day 1 of therapy to last bone scan assessment (up to 51.6 months)]

      Stable=no new lesions appeared at any 6-week assessment or new pain was not developed in an area that was previously visualized for a minimum of 18 weeks; no change=stable disease prior to 18 weeks and then discontinued treatment; progression=2 or more new areas of focal uptake or new adverse clinical symptoms in an area previously visualized; improved=disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, and new pain not developing in an area that was previously visualized.

    7. Percentage of Participants With Improvement on Bone Scan [From Day 1 of therapy to last bone scan assessment (up to 51.6 months)]

      Improvement=disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, and new pain not developing in an area that was previously visualized

    8. Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6 [At pretreatment visit and on Day 1 of Cycles 2 through 6, then Day 1 of every other cycle, at end of treatment, and at follow-up visit]

      The BPI-sf assessed intensity of pain in the last 24 hours as well as impact of pain on daily functions. Patients rated the severity of their pain at its worst, least, and average in the last 24 hours using an 11-point rating scale with endpoints of no pain (0 points) and pain as bad as you can imagine (11 points). They were asked to rate their present pain and pain at the time they completed the BPI-sf. Using an 11-point rating scale with endpoints of does not interfere (0 points) and completely interferes (11 points), the BPI-sf similarly assessed to what extent pain interfered with mood, walking, general activity, work, relations with others, sleep, and enjoyment of life. The BPI-sf also asked patients to mark the location of their pain on a body drawing and included other questions about pain treatment and the extent of pain relief. The BPI-sf was collected in the Phase 2 portion of the study only. For on-treatment visits, the BPI-sf was completed prior to the docetaxel infusion.

    9. Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Overall Population [From first dose Day 1 through at least 30 days after last dose of either dasatinib or docetaxel, whichever was later (up to approximately 49 months)]

      AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Leading to death.

    10. Number of Participants With Death as Outcome, Drug-related Serious Adverse Events (SAEs), Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Phase 2 Cohort [From first dose Day 1 through at least 30 days after last dose of either dasatinib or docetaxel, whichever was later (up to approximately 49 months)]

      AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Leading to death.

    11. Area Under the Concentration-time Curve (AUC) From 0 to 10 Hours Postdose (AUC [0-10])and AUC in 1 Dosing Interval, From Time 0 to 24 Hours (AUC[Tau])of Dasatinib Coadministered With Docetaxel [Cycle 1, Day 14 at 0, 0.5 , 1, 2, 3, 4, 7, 10, and 24 hours postdose]

    12. Maximum Observed Plasma Concentration (Cmax) of Dasatinib and of Docetaxel [Docetaxel: Cycle 1, Day 1 at 0, 0.5, 1, 1.25, 1.5, 2, 3, 4, 7, 10, 24, and 48 hours postdose; dasatanib: Cycle 1, Day 14 at 0, .5, 1, 2, 3, 4, 7, 10, and 24 hours postdose]

    13. Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity (AUC[Inf]) of Docetaxel [Cycle 1, Day 1 at 0, 0.5, 1, 1.25, 1.5, 2, 3, 4, 7, 10, 24, and 48 hours postdose]

    14. Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests [From Day 2 of Cycle 1 to up to 30 days after last dose of study drug (up to approximately 49 months)]

      ULN=upper limit of normal. Graded by Common Toxicity Criteria: 1 (least severe) to 4 (life threatening ). Absolute neutrophil count (*10^9/L), Grade 3, <1.0-0.5; Grade 4, <0.5. Hemoglobin (mmol/L), Grade 3, <4.9-4.0; Grade 4, <4.0. Platelets (*10^9/L), Grade 3, <50.0-25.0; Grade 4, <25.0. Leukocytes (*10^9/L) Grade 3, <2.0-1.0; Grade 4, <1.0. ALP, ALT, and AST (*ULN), Grade 3, >5.0-20.0; Grade 4, >20.0. Total bilirubin (*ULN), Grade 3, >3.0-10.0; Grade 4, >10.0. Creatinine (*ULN), Grade 3, >3.0-6.0; Grade 4, >6.0. Hypercalcemia (mmol/L), Grade 3, >3.1-3.4; Grade 4, >3.4. Hypocalcemia mmol/L), Grade 3, <1.75-1.5; Grade 4, <1.5. Hyperkalemia (mmol/L), Grade 3, >6.0-7.0; Grade 4, >7.0. Hypokalemia (mmol/L), Grade 3, <3.0-2.5; Grade 4, <2.5. Hypernatremia (mmol/L), Grade 3, >155-160; Grade 4, >160. Hyponatremia (mmol/L), Grade 3, <130-120; Grade 4, <120. Phosphorus (mmol/L), Grade 3, <0.6-0.3; Grade 4, <0.3. Prothrombin time (seconds), Grade 3, >2.0; Grade 4, not defined.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • Histologically or cytologically confirmed adenocarcinoma of the prostate that was clinically refractory to hormone therapy

    • Eastern Cooperative Oncology Group performance status of 0 - 2

    • Evidence of progressive metastatic disease at time of enrollment

    • Measurable disease on either computer tomography scan or magnetic resonance imaging or positive bone scan with any level of serum prostate specific antigen (PSA) ≥5 ng/ml. Patients with PSA ≥5 ng/ml only and no other radiographic evidence of metastatic prostate cancer were not eligible

    • Evidence of progressive disease since the most recent change in therapy. Progressive disease was defined as any one of the following:

    • Objective disease progression: Objective evidence of increase in radiographic lesions or the appearance of 1 or more new lesions

    • Bone scan progression: Appearance of either of the following: 2 or more new lesions on bone scan attributable to prostate cancer or 1 new lesion on bone scan attributable to prostate cancer in conjunction with a rising PSA

    • PSA progression: 2 consecutively rising PSA levels (≥5 ng/mL) separated by 2 weeks with a testosterone concentration of ≤50 ng/dL at 2 week intervals

    • Serum testosterone levels ≤50 ng/dL, determined within 2 weeks prior to starting treatment

    • Maintaining castrate status: patients who had not undergone surgical orchiectomy must have continued on medical therapies, such as gonadotropin-releasing hormone analogs, to maintain castrate levels of serum testosterone. Those receiving an antiandrogen as part of their first-line hormonal therapy must have shown progression of disease off of the antiandrogen prior to enrollment (6 weeks withdrawal for bicalutamide; 4 weeks for flutamide)

    Key Exclusion Criteria:

    • Sexually active fertile men not using effective birth control if their partners were women of child-bearing potential

    • Known brain metastases

    • Clinically-significant cardiovascular disease, including myocardial infarction or ventricular tachyarrhythmia within 6 months; prolonged heart rate-corrected QT interval (QTc) >450 msec; ejection fraction <40%, or major conduction abnormality (unless a cardiac pacemaker was present)

    • Pleural or pericardial effusion, due to concerns that the combination of docetaxel and dasatinib could worsen these events

    • Uncontrolled intercurrent illness including, ongoing or active infection, cardiac arrhythmia, or psychiatric illness/social situations that limit compliance with study requirements

    • Participants were permitted to continue on a daily multivitamin but all other herbal, alternative, and food supplements must have been discontinued before enrollment into the study

    • Ketoconazole must have been discontinued 4 weeks prior to enrollment

    • Patients were not permitted to receive radioactive bone targeting agents, such as Strontium or Samarian ,while on study treatment

    • The following restrictions on prior therapy for metastatic disease applied:

    • One chemotherapy regimen was permitted as long as docetaxel resistance or intolerance was not demonstrated. Docetaxel resistance was defined as objective disease progression or confirmed PSA progression during docetaxel therapy or within 3 months of treatment completion. Docetaxel intolerance was defined as toxicity requiring docetaxel interruption >4 weeks or dose modification below approved doses

    • No more than 1 prior course of palliative radiotherapy

    • Up to 1 prior treatment with a nonchemotherapeutic agent was permitted as treatment for metastatic prostate cancer

    • No prior radioisotope therapy with Strontium-89, Samarium, or similar agents

    • No limitation on prior hormonal therapy

    • QTc prolonging agents strongly associated with Torsade de Pointes arrhythmia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Chicago Chicago Illinois United States 60637
    2 Springfield Clinic Springfield Illinois United States 62703
    3 Hematology-Oncology Associates Of Rockland Nyack New York United States 10960
    4 Duke University Durham North Carolina United States 27710
    5 The University Of Texas Md Anderson Cancer Center Houston Texas United States 77030-4009

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT00439270
    Other Study ID Numbers:
    • CA180-086
    First Posted:
    Feb 23, 2007
    Last Update Posted:
    Mar 28, 2014
    Last Verified:
    Feb 1, 2014
    Keywords provided by Bristol-Myers Squibb
    Metastatic hormone refractory prostate cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Docetaxel
    Dasatinib

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail A total of 49 participants were enrolled in the study, and 46 entered the treatment period and received at least 1 dose of dasatinib.
    Arm/Group Title Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Dasatinib, 70 mg + Docetaxel, 75 mg/m^2 Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
    Arm/Group Description Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
    Period Title: Phase 1 (18.1 Months)
    STARTED 3 3 3 4 3
    COMPLETED 0 0 0 4 0
    NOT COMPLETED 3 3 3 0 3
    Period Title: Phase 1 (18.1 Months)
    STARTED 0 0 0 34 0
    COMPLETED 0 0 0 0 0
    NOT COMPLETED 0 0 0 34 0

    Baseline Characteristics

    Arm/Group Title Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Dasatinib, 70 mg + Docetaxel, 75 mg/m^2 Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Dasatinib, 120 mg + Docetaxel, 75 mg/m^2 Total
    Arm/Group Description Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Total of all reporting groups
    Overall Participants 3 3 3 34 3 46
    Age, Customized (Number) [Number]
    <65 years
    0
    (3.51) 0%
    1
    (5.03) 33.3%
    1
    (11.02) 33.3%
    19
    (8.43) 55.9%
    2
    (13.23) 66.7%
    23
    50%
    >=65 years
    3
    100%
    2
    66.7%
    2
    66.7%
    15
    44.1%
    1
    33.3%
    23
    50%
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Male
    3
    100%
    3
    100%
    3
    100%
    34
    100%
    3
    100%
    46
    100%
    Race/Ethnicity, Customized (Number) [Number]
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    4
    11.8%
    0
    0%
    4
    8.7%
    White
    3
    100%
    3
    100%
    3
    100%
    29
    85.3%
    3
    100%
    41
    89.1%
    Other
    0
    0%
    0
    0%
    0
    0%
    1
    2.9%
    0
    0%
    1
    2.2%
    Race/Ethnicity, Customized (Number) [Number]
    Hispanic/Latino
    0
    0%
    0
    0%
    0
    0%
    1
    2.9%
    0
    0%
    1
    2.2%
    Not Hispanic/Latino
    3
    100%
    3
    100%
    3
    100%
    33
    97.1%
    3
    100%
    45
    97.8%

    Outcome Measures

    1. Secondary Outcome
    Title Percentage of Participants With a Prostate Specific Antigen (PSA) Response
    Description PSA response rate is defined as a decrease of >=50% in PSA levels from baseline, sustained for at least 6 weeks and confirmed by at least 2 measurements
    Time Frame At pretreatment visit, and on Day 1 of Cycles 2 through 12, then every other cycle, where investigator deems appropriate, and at end of treatment (up to 51.6 months)

    Outcome Measure Data

    Analysis Population Description
    All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2
    Arm/Group Title Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
    Arm/Group Description Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
    Measure Participants 34
    Number (95% Confidence Interval) [Percentage of participants]
    64.7
    2156.7%
    2. Primary Outcome
    Title Maximum Tolerated Dose (MTD) of Dasatinib Administered With Docetaxel
    Description MTD was defined by dose-limiting toxicity (DLT) criteria. DLT was defined as grade 4 neutropenia causing treatment interruption for >14 days, febrile neutropenia, grade 4 thrombocytopenia, grade 3 thrombocytopenia with a bleeding episode requiring platelet transfusion, nausea and/or vomiting despite medical intervention/prophylaxis causing treatment interruption for >14 days, grade 3-4 asthenia/fatigue, any other grade >=3 nonhematologic toxicity except alopecia or transient arthralgia/myalgia (unless unresponsive to intervention), or interruption of study drug for >14 days due to toxicity. When defined, the MTD would serve as recommended Phase 2 dose of each drug in the combination of oral dasatinib and intravenous docetaxel.
    Time Frame From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42)

    Outcome Measure Data

    Analysis Population Description
    All patients who received at least 1 dose of dasatinib in Phase 1
    Arm/Group Title All Treated (Phase 1)
    Arm/Group Description Participants received dasatinib as 50, 70, 100, or 120 mg administered orally once daily with docetaxel, administered every 3 weeks as an infusion at 60 or 75 mg/m^2. A standard 3+3 design was used, in which 3-6 patients were exposed to a dose level combination. Using a dose escalation scheme, the first 3-6 patients received the lower dose level combination. Escalation to the next dose level combination for another set of 3-6 patients was initiated if no dose-limiting toxicities (DLTs) were observed. If 2 or more DLTs were observed for a dose level combination, the MTD was defined as the previous dose level combination.
    Measure Participants 16
    Number [mg]
    NA
    3. Secondary Outcome
    Title Duration of Prostate Specific Antigen (PSA) Response
    Description Duration of response is computed for participants with confirmed PSA response. It is measured in months from the time of the first of 2 consecutive measurements meeting the criteria for confirmed PSA response to the date of the first of 3 consecutive measurements that confirm PSA progression, the date of disease progression, or the date of death. Participants who neither progressed (PSA or disease) nor died were censored on the date of their last PSA assessment. PSA response is defined as a decrease of >=50% in PSA levels from baseline, sustained for at least 6 weeks and confirmed by at least 2 measurements. PSA progression is defined as 3 consecutive increases in PSA from baseline or nadir, each measurement at least 1 week apart. The final confirming PSA measurement had to be ≥5ng/mL higher than baseline or nadir and also represent at least a 50% increase from baseline or nadir (ie, the value is ≥1.5*baseline or nadir PSA).
    Time Frame At pretreatment visit, and on Day 1 of Cycles 2 through 12, then every other cycle, where investigator deems appropriate, and at end of treatment

    Outcome Measure Data

    Analysis Population Description
    All participants who received dasatinib, 100 mg + docetaxel, 75 mg/m^2 and who had a PSA response
    Arm/Group Title Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
    Arm/Group Description Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
    Measure Participants 22
    Median (95% Confidence Interval) [Months]
    9.5
    4. Secondary Outcome
    Title Number of Months of Progression-free Survival (PFS)
    Description PFS defined as time in months from the first dosing date to the date of disease progression or the date of death. Patients who neither progressed nor died were censored on the date of their last on-study prostate specific antigen (PSA) measurement, tumor assessment, or radionuclide bone scan assessment (whichever occurred last). Disease progression defined as either of the following: progression on radionuclide bone scan, death, or at least 2 of the following: tumor progression, as defined by modified Response Evaluation Criteria in Solid Tumors; PSA progression; or investigator-defined clinical progression based on physical examination, history, symptoms, and performance status.
    Time Frame Patients with an event: time from first dose to disease progression or death, whichever occurs first. Patients without an event: time to last on-study PSA measurement, tumor assessment, or radionuclide bone scan assessment, whichever occurs last

    Outcome Measure Data

    Analysis Population Description
    All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2
    Arm/Group Title Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
    Arm/Group Description Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
    Measure Participants 34
    Median (95% Confidence Interval) [Months]
    11.5
    5. Secondary Outcome
    Title Percentage of Participants With an Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
    Description Objective response rate is defined as the percentage of participants who have achieved best responses of confirmed Complete Response (CR) or Partial Response (PR) where confirmed requires repeat evaluations for a minimum of 4 weeks after the criteria for response are first met. RECIST: CR=disappearance of clinical and radiologic evidence of target lesions; PR=a 30% or greater decrease in the sum of the longest diameter (LD) of all lesions in reference to the baseline sum LD.
    Time Frame Pretreatment visit then every 6 weeks thereafter (up to 51.6 months)

    Outcome Measure Data

    Analysis Population Description
    All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2
    Arm/Group Title Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
    Arm/Group Description Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
    Measure Participants 34
    Number (95% Confidence Interval) [Percentage of participants]
    44.1
    1470%
    6. Secondary Outcome
    Title Number of Participants by Best On-study Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
    Description RECIST for target lesions: Complete Response (CR)=disappearance of clinical and radiologic evidence of target lesions. Partial Response (PR)=a 30% or greater decrease in the sum of the longest diameter (LD) of all lesions in reference to the baseline sum LD. Stable disease (SD)=neither sufficient increase to qualify for Progressive Disease (PD) nor sufficient shrinkage to qualify for PR. PD=a 20% or greater increase in the sum of LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline; unequivocal progression of nonmeasurable disease/lesions as evaluated by CT scan or MRI (not as evaluated by radionuclide bone scan) and/or new lesions are present. To qualify as SD, patients had to exhibit SD for a minimum of 18 weeks. Those with evaluations noted as SD prior to 18 weeks and discontinued were reported as no change.
    Time Frame Pretreatment visit then every 6 weeks thereafter (up to 51.6 months)

    Outcome Measure Data

    Analysis Population Description
    All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2
    Arm/Group Title Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
    Arm/Group Description Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
    Measure Participants 34
    Complete response
    0
    0%
    Partial response
    15
    500%
    Stable disease
    1
    33.3%
    No change
    3
    100%
    Progressive disease
    2
    66.7%
    Not evaluable
    13
    433.3%
    7. Primary Outcome
    Title Recommended Phase 2 Dose of Dasatinib Administered With Docetaxel, 75 mg/m^2
    Description Because no dose-limiting toxicities occurred, the recommended dose of dasatinib used in Phase 2 was based on findings from ongoing studies in chronic myelogenous leukemia and experience from the previous Phase 2 study of single-agent dasatinib in chronic refractory prostate cancer. The recommended Phase 2 dose of docetaxel (75 mg/m^2) was based on the docetaxel package insert.
    Time Frame From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42)

    Outcome Measure Data

    Analysis Population Description
    All patients who received at least 1 dose of dasatinib in Phase 1
    Arm/Group Title All Treated (Phase 1)
    Arm/Group Description Participants received dasatinib as 50, 70, 100, or 120 mg administered orally once daily with docetaxel, administered every 3 weeks as an infusion at 60 or 75 mg/m^2. A standard 3+3 design was used, in which 3-6 patients were exposed to a dose level combination. Using a dose escalation scheme, the first 3-6 patients received the lower dose level combination. Escalation to the next dose level combination for another set of 3-6 patients was initiated if no dose-limiting toxicities (DLTs) were observed. If, for a dose level combination, 2 or more DLTs were observed, the maximum tolerated dose was defined as the previous dose level combination.
    Measure Participants 16
    Number [mg]
    100
    8. Secondary Outcome
    Title Number of Participants by Best On-study Bone Scan Assessment From Baseline
    Description Stable=no new lesions appeared at any 6-week assessment or new pain was not developed in an area that was previously visualized for a minimum of 18 weeks; no change=stable disease prior to 18 weeks and then discontinued treatment; progression=2 or more new areas of focal uptake or new adverse clinical symptoms in an area previously visualized; improved=disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, and new pain not developing in an area that was previously visualized.
    Time Frame From Day 1 of therapy to last bone scan assessment (up to 51.6 months)

    Outcome Measure Data

    Analysis Population Description
    All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2
    Arm/Group Title Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
    Arm/Group Description Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
    Measure Participants 34
    Improved
    8
    266.7%
    Stable
    17
    566.7%
    No change
    7
    233.3%
    Progression
    1
    33.3%
    Not evaluable
    1
    33.3%
    9. Secondary Outcome
    Title Percentage of Participants With Improvement on Bone Scan
    Description Improvement=disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, and new pain not developing in an area that was previously visualized
    Time Frame From Day 1 of therapy to last bone scan assessment (up to 51.6 months)

    Outcome Measure Data

    Analysis Population Description
    All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2
    Arm/Group Title Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
    Arm/Group Description Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
    Measure Participants 34
    Number (95% Confidence Interval) [Percentage of participants]
    23.5
    783.3%
    10. Secondary Outcome
    Title Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6
    Description The BPI-sf assessed intensity of pain in the last 24 hours as well as impact of pain on daily functions. Patients rated the severity of their pain at its worst, least, and average in the last 24 hours using an 11-point rating scale with endpoints of no pain (0 points) and pain as bad as you can imagine (11 points). They were asked to rate their present pain and pain at the time they completed the BPI-sf. Using an 11-point rating scale with endpoints of does not interfere (0 points) and completely interferes (11 points), the BPI-sf similarly assessed to what extent pain interfered with mood, walking, general activity, work, relations with others, sleep, and enjoyment of life. The BPI-sf also asked patients to mark the location of their pain on a body drawing and included other questions about pain treatment and the extent of pain relief. The BPI-sf was collected in the Phase 2 portion of the study only. For on-treatment visits, the BPI-sf was completed prior to the docetaxel infusion.
    Time Frame At pretreatment visit and on Day 1 of Cycles 2 through 6, then Day 1 of every other cycle, at end of treatment, and at follow-up visit

    Outcome Measure Data

    Analysis Population Description
    All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2, in the Phase 2 portion of the study and completed the BPI-sf at baseline. n=evaluable participants in that cycle.
    Arm/Group Title Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 (Phase 2 )
    Arm/Group Description Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
    Measure Participants 18
    Baseline: Average of pain (n=18)
    1.0
    Baseline: Average of pain interference (n=18)
    1.0
    Cycle 2: Average of pain (n=11)
    -0.8
    Cycle 2: Average of pain interference (n=11)
    0.0
    Cycle 3: Average of pain (n=7)
    -0.5
    Cycle 3: Average of pain interference (n=7)
    -0.0
    Cycle 4: Average of pain (n=10)
    -1.0
    Cycle 4: Average of pain interference (n=10)
    -0.1
    Cycle 5: Average of pain (n=5)
    -0.8
    Cycle 5: Average of pain interference (n=5)
    0.0
    Cycle 6: Average of pain (n=9)
    -0.8
    Cycle 6: Average of pain interference (n=9)
    0.0
    11. Secondary Outcome
    Title Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Overall Population
    Description AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Leading to death.
    Time Frame From first dose Day 1 through at least 30 days after last dose of either dasatinib or docetaxel, whichever was later (up to approximately 49 months)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of dasatinib
    Arm/Group Title All Treated
    Arm/Group Description Participants received dasatinib, 50, 70, 100, or 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 or 75 mg/m^2.
    Measure Participants 46
    Deaths
    3
    100%
    SAEs
    17
    566.7%
    Drug-related SAEs
    8
    266.7%
    Drug-related AEs
    45
    1500%
    Drug-related AEs leading to discontinuation
    7
    233.3%
    Drug-related Grade 3 or 4 AEs
    13
    433.3%
    12. Secondary Outcome
    Title Number of Participants With Death as Outcome, Drug-related Serious Adverse Events (SAEs), Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Phase 2 Cohort
    Description AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Leading to death.
    Time Frame From first dose Day 1 through at least 30 days after last dose of either dasatinib or docetaxel, whichever was later (up to approximately 49 months)

    Outcome Measure Data

    Analysis Population Description
    All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2
    Arm/Group Title Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
    Arm/Group Description Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
    Measure Participants 34
    Deaths
    2
    66.7%
    Drug-related SAEs
    7
    233.3%
    Drug-related AEs
    33
    1100%
    Drug-related AEs leading to discontinuation
    6
    200%
    Drug-related Grade 3 or 4 AEs
    12
    400%
    13. Secondary Outcome
    Title Area Under the Concentration-time Curve (AUC) From 0 to 10 Hours Postdose (AUC [0-10])and AUC in 1 Dosing Interval, From Time 0 to 24 Hours (AUC[Tau])of Dasatinib Coadministered With Docetaxel
    Description
    Time Frame Cycle 1, Day 14 at 0, 0.5 , 1, 2, 3, 4, 7, 10, and 24 hours postdose

    Outcome Measure Data

    Analysis Population Description
    All patients who received at least 1 dose of dasatinib; n=number of patients who were evaluable
    Arm/Group Title Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Dasatinib, 70 mg + Docetaxel, 75 mg/m^2 Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
    Arm/Group Description Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
    Measure Participants 3 3 3 34 3
    AUC(0-10) (n=3, 1, 3, 28, 3)
    173.13
    (54)
    71.75
    (NA)
    149.79
    (26)
    277.07
    (54)
    461.82
    (35)
    AUC(tau) (n=3, 1, 3, 21, 3)
    205.43
    (57)
    82.20
    (NA)
    200.63
    (25)
    389.66
    (48)
    556.47
    (36)
    14. Secondary Outcome
    Title Maximum Observed Plasma Concentration (Cmax) of Dasatinib and of Docetaxel
    Description
    Time Frame Docetaxel: Cycle 1, Day 1 at 0, 0.5, 1, 1.25, 1.5, 2, 3, 4, 7, 10, 24, and 48 hours postdose; dasatanib: Cycle 1, Day 14 at 0, .5, 1, 2, 3, 4, 7, 10, and 24 hours postdose

    Outcome Measure Data

    Analysis Population Description
    All patients who received at least 1 dose of dasatinib; n=number of patients who were evaluable
    Arm/Group Title Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Dasatinib, 70 mg + Docetaxel, 75 mg/m^2 Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
    Arm/Group Description Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
    Measure Participants 3 3 3 34 3
    Dasatinib (n=3, 1, 3, 29, 3)
    42.70
    (68)
    21.99
    (NA)
    30.00
    (17)
    83.91
    (74)
    164.99
    (26)
    Docetaxel (n=3, 3, 3, 34, 3)
    2226.25
    (46)
    1763.34
    (25)
    1748.43
    (20)
    2125.49
    (33)
    2412.41
    (14)
    15. Secondary Outcome
    Title Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity (AUC[Inf]) of Docetaxel
    Description
    Time Frame Cycle 1, Day 1 at 0, 0.5, 1, 1.25, 1.5, 2, 3, 4, 7, 10, 24, and 48 hours postdose

    Outcome Measure Data

    Analysis Population Description
    All patients who received at least 1 dose of dasatinib
    Arm/Group Title Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Dasatinib, 70 mg + Docetaxel, 75 mg/m^2 Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
    Arm/Group Description Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
    Measure Participants 3 3 3 34 3
    Geometric Mean (Geometric Coefficient of Variation) [ng.h/mL]
    3085.59
    (54)
    2064.49
    (24)
    2113.37
    (23)
    2663.83
    (33)
    3283.27
    (19)
    16. Secondary Outcome
    Title Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests
    Description ULN=upper limit of normal. Graded by Common Toxicity Criteria: 1 (least severe) to 4 (life threatening ). Absolute neutrophil count (*10^9/L), Grade 3, <1.0-0.5; Grade 4, <0.5. Hemoglobin (mmol/L), Grade 3, <4.9-4.0; Grade 4, <4.0. Platelets (*10^9/L), Grade 3, <50.0-25.0; Grade 4, <25.0. Leukocytes (*10^9/L) Grade 3, <2.0-1.0; Grade 4, <1.0. ALP, ALT, and AST (*ULN), Grade 3, >5.0-20.0; Grade 4, >20.0. Total bilirubin (*ULN), Grade 3, >3.0-10.0; Grade 4, >10.0. Creatinine (*ULN), Grade 3, >3.0-6.0; Grade 4, >6.0. Hypercalcemia (mmol/L), Grade 3, >3.1-3.4; Grade 4, >3.4. Hypocalcemia mmol/L), Grade 3, <1.75-1.5; Grade 4, <1.5. Hyperkalemia (mmol/L), Grade 3, >6.0-7.0; Grade 4, >7.0. Hypokalemia (mmol/L), Grade 3, <3.0-2.5; Grade 4, <2.5. Hypernatremia (mmol/L), Grade 3, >155-160; Grade 4, >160. Hyponatremia (mmol/L), Grade 3, <130-120; Grade 4, <120. Phosphorus (mmol/L), Grade 3, <0.6-0.3; Grade 4, <0.3. Prothrombin time (seconds), Grade 3, >2.0; Grade 4, not defined.
    Time Frame From Day 2 of Cycle 1 to up to 30 days after last dose of study drug (up to approximately 49 months)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug
    Arm/Group Title Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Dasatinib, 70 mg + Docetaxel, 75 mg/m^2 Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
    Arm/Group Description Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
    Measure Participants 3 3 3 34 3
    Absolute neutrophil count
    0
    0%
    0
    0%
    0
    0%
    1
    2.9%
    0
    0%
    Hemoglobin
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Platelet count
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Leukocytes
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Alanine aminotransferase (ALT)
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Aspartate aminotransferase (AST)
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Alkaline phosphatase (ALP)
    1
    33.3%
    1
    33.3%
    0
    0%
    1
    2.9%
    0
    0%
    Total bilirubin
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hypercalcemia
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hypocalcemia
    0
    0%
    0
    0%
    0
    0%
    1
    2.9%
    0
    0%
    Creatinine
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hyperkalemia
    0
    0%
    0
    0%
    0
    0%
    1
    2.9%
    0
    0%
    Hypokalemia
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    Hypernatremia
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hyponatremia
    0
    0%
    0
    0%
    0
    0%
    2
    5.9%
    0
    0%
    Phosphorus, inorganic
    0
    0%
    1
    33.3%
    0
    0%
    1
    2.9%
    0
    0%
    Prothrombin time
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Adverse Events

    Time Frame From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
    Adverse Event Reporting Description
    Arm/Group Title Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Dasatinib, 120 mg + Docetaxel, 75 mg/m^2 Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
    Arm/Group Description Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
    All Cause Mortality
    Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Dasatinib, 120 mg + Docetaxel, 75 mg/m^2 Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Dasatinib, 120 mg + Docetaxel, 75 mg/m^2 Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 14/34 (41.2%) 1/3 (33.3%) 1/3 (33.3%) 0/3 (0%) 1/3 (33.3%)
    Blood and lymphatic system disorders
    Leukopenia 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Neutropenia 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Anaemia 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Febrile neutropenia 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Cardiac disorders
    Atrial fibrillation 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Cardiac failure congestive 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Diastolic dysfunction 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Gastrointestinal disorders
    Constipation 0/34 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%)
    Abdominal pain 0/34 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%)
    General disorders
    Mucosal inflammation 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Fatigue 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Pyrexia 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Asthenia 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Immune system disorders
    Drug hypersensitivity 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Infections and infestations
    Bronchitis 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Cellulitis 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Subcutaneous abscess 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Pneumonia 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Sepsis 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Gastroenteritis viral 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Infection 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Metabolism and nutrition disorders
    Dehydration 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Musculoskeletal and connective tissue disorders
    Bone pain 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Spinal column stenosis 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Musculoskeletal pain 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm malignant 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Nervous system disorders
    Syncope 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Spinal cord compression 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Cerebral ischaemia 0/34 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%)
    Psychiatric disorders
    Confusional state 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Renal and urinary disorders
    Renal failure acute 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Chronic obstructive pulmonary disease 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Aspiration 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Pleural effusion 4/34 (11.8%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Pulmonary embolism 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Vascular disorders
    Hypotension 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Other (Not Including Serious) Adverse Events
    Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Dasatinib, 120 mg + Docetaxel, 75 mg/m^2 Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 34/34 (100%) 3/3 (100%) 3/3 (100%) 3/3 (100%) 3/3 (100%)
    Blood and lymphatic system disorders
    Leukopenia 0/34 (0%) 0/3 (0%) 1/3 (33.3%) 1/3 (33.3%) 1/3 (33.3%)
    Granulocytopenia 0/34 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%)
    Anaemia 10/34 (29.4%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1/3 (33.3%)
    Cardiac disorders
    Atrial fibrillation 2/34 (5.9%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%)
    Tachycardia 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Angina pectoris 0/34 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Ear and labyrinth disorders
    Tinnitus 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Eye disorders
    Dry eye 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Eye pain 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Lacrimation increased 4/34 (11.8%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Vision blurred 2/34 (5.9%) 1/3 (33.3%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%)
    Gastrointestinal disorders
    Vomiting 9/34 (26.5%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%)
    Oral pain 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Constipation 9/34 (26.5%) 2/3 (66.7%) 2/3 (66.7%) 1/3 (33.3%) 0/3 (0%)
    Abdominal pain lower 0/34 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Nausea 20/34 (58.8%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1/3 (33.3%)
    Dyspepsia 5/34 (14.7%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Mouth ulceration 0/34 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%)
    Stomatitis 3/34 (8.8%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Ascites 3/34 (8.8%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Diarrhoea 25/34 (73.5%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%)
    Gastrooesophageal reflux disease 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%)
    Rectal haemorrhage 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    General disorders
    Face oedema 0/34 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%)
    Pain 6/34 (17.6%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%)
    Fatigue 27/34 (79.4%) 1/3 (33.3%) 3/3 (100%) 1/3 (33.3%) 3/3 (100%)
    Pyrexia 6/34 (17.6%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Asthenia 5/34 (14.7%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%)
    Oedema 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Chest pain 3/34 (8.8%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Chills 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Influenza like illness 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%)
    Injection site reaction 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Oedema peripheral 14/34 (41.2%) 1/3 (33.3%) 1/3 (33.3%) 1/3 (33.3%) 1/3 (33.3%)
    Immune system disorders
    Hypersensitivity 4/34 (11.8%) 0/3 (0%) 2/3 (66.7%) 1/3 (33.3%) 0/3 (0%)
    Infections and infestations
    Bronchitis 0/34 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Sinusitis 4/34 (11.8%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Urinary tract infection 6/34 (17.6%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%)
    Localised infection 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Rhinitis 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Tinea cruris 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%)
    Infection 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Upper respiratory tract infection 3/34 (8.8%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Injury, poisoning and procedural complications
    Laceration 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Contusion 4/34 (11.8%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%)
    Fall 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Rib fracture 3/34 (8.8%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Investigations
    Blood lactate dehydrogenase increased 1/34 (2.9%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Weight decreased 5/34 (14.7%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%)
    Alanine aminotransferase increased 0/34 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%)
    Blood uric acid increased 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Aspartate aminotransferase increased 0/34 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1/3 (33.3%)
    Cardiac murmur 0/34 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%)
    Haemoglobin decreased 3/34 (8.8%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%)
    Blood creatinine increased 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Blood urea increased 0/34 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%)
    Electrocardiogram QT prolonged 0/34 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Weight increased 0/34 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%)
    Activated partial thromboplastin time shortened 0/34 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%)
    Metabolism and nutrition disorders
    Hypoalbuminaemia 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%)
    Hypocalcaemia 1/34 (2.9%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%)
    Hypokalaemia 4/34 (11.8%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%)
    Hyperglycaemia 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1/3 (33.3%)
    Hyponatraemia 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Decreased appetite 17/34 (50%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%)
    Hypophosphataemia 0/34 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%)
    Dehydration 3/34 (8.8%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Musculoskeletal and connective tissue disorders
    Back pain 5/34 (14.7%) 2/3 (66.7%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Bone pain 4/34 (11.8%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%)
    Neck pain 3/34 (8.8%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Pain in extremity 6/34 (17.6%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Muscular weakness 3/34 (8.8%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Arthralgia 9/34 (26.5%) 2/3 (66.7%) 1/3 (33.3%) 0/3 (0%) 1/3 (33.3%)
    Musculoskeletal chest pain 2/34 (5.9%) 2/3 (66.7%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Myalgia 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%)
    Flank pain 0/34 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Musculoskeletal pain 2/34 (5.9%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Seborrhoeic keratosis 0/34 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%)
    Nervous system disorders
    Headache 6/34 (17.6%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%)
    Hypoaesthesia 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Neuropathy peripheral 6/34 (17.6%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Dysgeusia 17/34 (50%) 2/3 (66.7%) 2/3 (66.7%) 0/3 (0%) 1/3 (33.3%)
    Dizziness 3/34 (8.8%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/3 (66.7%)
    Peripheral sensory neuropathy 4/34 (11.8%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Psychiatric disorders
    Insomnia 6/34 (17.6%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Depression 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Anxiety 4/34 (11.8%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Renal and urinary disorders
    Incontinence 0/34 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%)
    Urinary hesitation 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Urinary retention 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Urethral pain 0/34 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Urinary bladder haemorrhage 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Pollakiuria 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Proteinuria 1/34 (2.9%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Urinary incontinence 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 16/34 (47.1%) 1/3 (33.3%) 1/3 (33.3%) 1/3 (33.3%) 0/3 (0%)
    Epistaxis 3/34 (8.8%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Apnoea 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Pneumonitis 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Chronic obstructive pulmonary disease 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Cough 7/34 (20.6%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Productive cough 0/34 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%)
    Pleural effusion 8/34 (23.5%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Skin and subcutaneous tissue disorders
    Nail disorder 8/34 (23.5%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Dry skin 8/34 (23.5%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Ecchymosis 2/34 (5.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Erythema 2/34 (5.9%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%)
    Rash 5/34 (14.7%) 2/3 (66.7%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%)
    Alopecia 25/34 (73.5%) 1/3 (33.3%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%)
    Vascular disorders
    Thrombosis 0/34 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%)
    Hot flush 5/34 (14.7%) 1/3 (33.3%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%)
    Hypertension 1/34 (2.9%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%)
    Flushing 2/34 (5.9%) 1/3 (33.3%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%)
    Hypotension 1/34 (2.9%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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 Bristol-Myers Squibb Study Director
    Organization Bristol-Myers Squibb
    Phone
    Email Clinical.Trials@bms.com
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT00439270
    Other Study ID Numbers:
    • CA180-086
    First Posted:
    Feb 23, 2007
    Last Update Posted:
    Mar 28, 2014
    Last Verified:
    Feb 1, 2014