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Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia

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ClinicalTrials.gov Identifier: NCT00306202
Recruitment Status : Active, not recruiting
First Posted : March 23, 2006
Results First Posted : July 23, 2012
Last Update Posted : September 26, 2017
Sponsor:
Collaborator:
Innovative Therapies For Children with Cancer Consortium
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Leukemia
Intervention: Drug: Dasatinib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose

Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).

Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained.

Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose

Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).

Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained.

Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.

Participant Flow:   Overall Study
    Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose   Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose   Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose
STARTED   17 [1]   17 [2]   24 [3] 
COMPLETED   11 [4]   16 [4]   24 [4] 
NOT COMPLETED   6   1   0 
Still on treatment                6                1                0 
[1] Started = Treated. 18 were enrolled; 1 no longer met study criteria and was never treated
[2] Started=Treated. 20 were enrolled;3 never treated(2 no longer met study criteria;1 withdrew consent)
[3] Started = Treated. 24 were enrolled; 1 no longer met study criteria and was never treated
[4] Completed = Off-treatment



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose

Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).

Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained.

Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose

Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).

Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained.

Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
Total Total of all reporting groups

Baseline Measures
   Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose   Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose   Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   17   24   58 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.4  (4.1)   9.7  (4.3)   8.6  (5.6)   10.0  (5.0) 
Age, Customized 
[Units: Participants]
       
< 2   0   0   2   2 
Between 2 and 6 years   2   5   7   14 
Between 7 and 11 years   6   5   7   18 
Between 12 and 18 years   9   7   7   23 
> 18   0   0   1   1 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      6  35.3%      5  29.4%      8  33.3%      19  32.8% 
Male      11  64.7%      12  70.6%      16  66.7%      39  67.2% 
Race/Ethnicity, Customized 
[Units: Participants]
       
White   16   15   21   52 
Black/African American   0   0   1   1 
Asian   1   1   1   3 
Other   0   1   1   2 
Race/Ethnicity, Customized 
[Units: Participants]
       
Not Hispanic/Latino   0   1   0   1 
Not Reported   17   16   24   57 
Region of Enrollment 
[Units: Participants]
       
France   6   4   5   15 
Austria   0   0   3   3 
Netherlands   2   5   6   13 
Germany   3   2   3   8 
Italy   1   2   5   8 
United Kingdom   5   4   2   11 
Extramedullary Disease Involvement [1] 
[Units: Participants]
       
Outside Spleen or Liver (involvement of CNS)   0   5   6   11 
Spleen (participants with splenomegaly)   0   2   2   4 
Liver (participants with hepatomegaly)   1   4   1   6 
[1] Participants could be categorized in more than 1 category. CNS = central nervous system
White Blood Cells in Peripheral Blood 
[Units: Cells/mm^3]
Median (Full Range)
 8.7 
 (3.6 to 134.6) 
 6.2 
 (0.6 to 197.0) 
 3.0 
 (0.7 to 20.0) 
 5.8 
 (0.6 to 197.0) 
White Blood Cells in Peripheral Blood 
[Units: Participants]
       
< 20000/mm^3   16   12   22   50 
>=20000/mm^3   1   5   2   8 
Hemoglobin in Peripheral Blood 
[Units: g/dL]
Median (Full Range)
 12.2 
 (9.5 to 16.0) 
 10.0 
 (7.7 to 13.5) 
 10.2 
 (7.1 to 13.6) 
 11.0 
 (7.1 to 16.0) 
Platelets in Peripheral Blood 
[Units: Cells/mm^3]
Median (Full Range)
 294.0 
 (139.0 to 1058.0) 
 82.0 
 (3.0 to 312.0) 
 41.0 
 (3.0 to 226.0) 
 86.0 
 (3.0 to 1058.0) 
Basophils in Peripheral Blood [1] 
[Units: Percentage of participants]
Median (Full Range)
 0.9 
 (0.0 to 9.0) 
 0.2 
 (0.0 to 4.5) 
 0.0 
 (0.0 to 2.0) 
 0.0 
 (0.0 to 9.0) 
[1] n = 9, 10, 19; n = number of participants with measures available
Basophils in Bone Marrow [1] 
[Units: Percentage]
Median (Full Range)
 0.6 
 (0.0 to 2.0) 
 0.0 
 (0.0 to 0.2) 
 0.0 
 (0.0 to 0.8) 
 0.0 
 (0.0 to 2.0) 
[1] n = 13, 12, 19; n = number of participants with measures available
Blasts in Peripheral Blood [1] 
[Units: Percentage of participants]
Median (Full Range)
 0.0 
 (0.0 to 1.0) 
 0.0 
 (0.0 to 88.0) 
 18.0 
 (0.0 to 92.0) 
 2.5 
 (0.0 to 92.0) 
[1] n = 9, 9, 19; n = number of participants with measures available
Blasts in Bone Marrow [1] 
[Units: Percentage]
Median (Full Range)
 0.0 
 (0.0 to 4.0) 
 39.0 
 (0.0 to 95.0) 
 79.9 
 (24.0 to 98.0) 
 52.0 
 (0.0 to 98.0) 
[1] n = 15, 16, 24; n = number of participants with measures available.
Promyelocytes in Bone Marrow [1] 
[Units: Percentage]
Median (Full Range)
 3.0 
 (0.0 to 43.0) 
 0.5 
 (0.0 to 6.0) 
 0.4 
 (0.0 to 4.0) 
 0.8 
 (0.0 to 43.0) 
[1] n = 12, 12, 19; n = number of participants with measures available
Lansky Play Score [1] 
[Units: Participants]
       
<60   0   0   0   0 
60 - 70   1   2   3   6 
80 - 90   1   2   3   6 
100   7   4   2   13 
Not Reported   8   9   16   33 
[1]

Used in children between 1 to 16 years of age to measure functional impairment. Scores range from 0-100 units on a scale; lower the score, worse the survival.

10-40:Moderate to severe restriction. 50:Gets dressed but inactive much of day; no active play, able to participate in quiet play. 60:Out of bed, but minimal active play; keeps busy with quiet activities. 70:Substantial restriction of, and less time spent, in play. 80:Active, but tires quickly. 90:Minor restrictions in physically strenuous activity. 100: Fully active, normal. Not reported=no Karnofsky Performance Score reported.

Karnofsky Performance Score [1] 
[Units: Participants]
       
<60   0   0   0   0 
60 - 70   0   1   1   2 
80 - 90   1   4   11   16 
100   7   4   4   15 
Not Reported   9   8   8   25 
[1]

Classifies patients according to their functional impairment. Scores range from 0-100 units on a scale, the lower the score, the worse the survival for most serious illnesses.

<=60: Needs increasing assistance up to Death (0). 70: Cares for self. Unable to carry on normal activity or to do active work. 80: Normal activity with effort; some signs or symptoms of disease. 90: Able to carry on normal activities; minor signs or symptoms of disease. 100: Normal, no complaints. Not reported=no Lansky Play Score reported.



  Outcome Measures

1.  Primary:   Recommended Phase II Dose of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia   [ Time Frame: From the date of first dose to end-of-treatment (EOT) (Median duration of therapy in months: Stratum 1=24.11 [Range:2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) ]

2.  Secondary:   Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0.   [ Time Frame: From the date of first dose until at least 30 days after the last dose of study drug (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) ]

3.  Secondary:   Number of Participants With Dose-limiting Toxicity (DLT)   [ Time Frame: From the date of first dose until at least 30 days after the last dose of study drug (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) ]

4.  Secondary:   Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0   [ Time Frame: Days 8, 15, 22, 29, 36, 43, then every 3 weeks, then every 3 months after 1 Year, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) ]

5.  Secondary:   Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0   [ Time Frame: Days 22 and 43, then every 12 weeks, then every 24 weeks after 24 months of treatment, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) ]

6.  Secondary:   Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0   [ Time Frame: Days 22 and 43, then every 12 weeks, then every 24 weeks after 24 months of treatment, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) ]

7.  Secondary:   Number of Participants With Major Cytogenetic Response (MCyR) at Any Time in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)   [ Time Frame: Strata 1 and 2/3: At Week 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Week 4, 19, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]) ]

8.  Secondary:   Number of Participants With Major Cytogenetic Response (MCyR) in Stratum 1 (Ph+ CP-CML) Within First 12 and 24 Weeks   [ Time Frame: After completion of Week 12 and 24 (measured at Weeks 13 and 25) ]

9.  Secondary:   Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)   [ Time Frame: Strata 1 and 2/3: At Weeks 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Weeks 4, 19, 25, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]) ]

10.  Secondary:   Percentage of Participants With Complete Cytogenetic Response (CCyR) or Major Cytogenetic Response (MCyR) at Recommended Phase II Dose   [ Time Frame: Strata 1 and 2/3: At Week 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Week 4, 19, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]) ]

11.  Secondary:   Time to Major Cytogenetic Response (MCyR) in Responders: Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)   [ Time Frame: Strata 1 and 2/3: At Weeks 7, 13, 25, 37, then every 12 weeks; Stratum 2/3: Additionally at Weeks 4, 19, 31; until first MCyR (maximum participant time to first MCyR of 92 days). ]

12.  Secondary:   Duration of Major Cytogenetic Response (MCyR) in Responders (Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML])   [ Time Frame: From the date of first MCyR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 48.6 months) ]

13.  Secondary:   Duration of Complete Cytogenetic Response (CCyR) in Responders: Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML]   [ Time Frame: From the date of first CCyR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 45.1 months) ]

14.  Secondary:   Number of Participants With Major Hematologic Response (MaHR) at Any Time in Stratum 2/3 (Ph+ ALL or AP/BP-CML) and Stratum 4 (Ph- ALL/AML)   [ Time Frame: Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; at Week 10 (only stratum 4); then every 12 weeks upto 24 months; then once/year; EOT(Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) ]

15.  Secondary:   Number of Participants With Major Hematologic Response (MaHR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML) Within First 6 and 24 Weeks   [ Time Frame: After completion of Week 6 and 24 (measured at weeks 7 and 25) ]

16.  Secondary:   Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML)   [ Time Frame: Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]) ]

17.  Secondary:   Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML)   [ Time Frame: Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks up to 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72]) ]

18.  Secondary:   Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML)   [ Time Frame: Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 10, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 4=1.14 [Range: 0.03-3.38]) ]

19.  Secondary:   Time to Major Hematologic Response (MaHR): Stratum 2/3 (PH+ ALL or AP/BP-CML)   [ Time Frame: Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; until confirmed MaHR (maximum participant time to first MaHR of 44 days). ]

20.  Secondary:   Time to Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML)   [ Time Frame: Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; at Week 4, 19, 31 (only stratum 2/3); then every 12 weeks upto 24 months; then once/year; until criteria was first met for CHR (maximum participant time to first CHR of 65 days). ]

21.  Secondary:   Duration of Major Hematologic Response (MaHR): Stratum 2/3 (Ph+ALL or AP/BP-CML)   [ Time Frame: From the date of first confirmed MaHR to date of progression, death, or last tumor assessment (maximum participant duration of response of 37 months). ]

22.  Secondary:   Duration of Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML)   [ Time Frame: From the date of first confirmed CHR to date of progression, death, or last tumor assessment (maximum participant duration of response of 50 months). ]

23.  Secondary:   Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 1 (Ph+ CP-CML)   [ Time Frame: Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]) ]

24.  Secondary:   Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 2/3 (Ph+ALL or AP/BP-CML)   [ Time Frame: Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72]) ]

25.  Secondary:   Number of Participants With Molecular Responses in Stratum 1 (Ph+ CP-CML)   [ Time Frame: At baseline (within 3 weeks before initiation of study therapy), After hematologic response, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]) ]

26.  Secondary:   Number of Participants With Major Molecular Response (MMR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML)   [ Time Frame: At baseline (within 3 weeks before initiation of study therapy), After hematologic response, EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72]) ]

27.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: From the date of randomization to date of progression, death, last tumor assessment, or 5 years after EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) ]

28.  Secondary:   Overall Survival (OS)   [ Time Frame: From start of study therapy until death or 5 years after EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) ]

29.  Secondary:   Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) by Age Group   [ Time Frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). ]

30.  Secondary:   Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Age Group   [ Time Frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). ]

31.  Secondary:   Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Observed Maximum Plasma Concentration (Cmax) by Age Group   [ Time Frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). ]

32.  Secondary:   Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Age Group   [ Time Frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). ]

33.  Secondary:   Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Age Group   [ Time Frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). ]

34.  Secondary:   Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group   [ Time Frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). ]

35.  Secondary:   Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group   [ Time Frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). ]

36.  Secondary:   Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group   [ Time Frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). ]

37.  Secondary:   Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group   [ Time Frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). ]

38.  Secondary:   Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group   [ Time Frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). ]

39.  Secondary:   Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group   [ Time Frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). ]

40.  Secondary:   Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group   [ Time Frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). ]

41.  Secondary:   Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group   [ Time Frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). ]

42.  Secondary:   Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group   [ Time Frame: 4 hours after oral dose ]

43.  Secondary:   Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML   [ Time Frame: At baseline (within 3 weeks before initiation of study therapy) ]

44.  Secondary:   Number of Participants With BCR-ABL Mutations at End-of-Treatment: Stratum1 Ph+ CP-CML and Stratum2/3 Ph+ ALL or AP/BP-CML   [ Time Frame: At EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]) ]

45.  Secondary:   Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at Baseline   [ Time Frame: At baseline (within 3 weeks before initiation of study therapy) ]

46.  Secondary:   Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at End-Of-Treatment   [ Time Frame: At EOT (Median duration of therapy in months: Stratum 4=1.14 [Range: 0.03-3.38]) ]

47.  Other Pre-specified:   Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0   [ Time Frame: At baseline (within 1 week before initiation of study therapy) ]

48.  Other Pre-specified:   Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0   [ Time Frame: At baseline (within 1 week before initiation of study therapy) ]

49.  Other Pre-specified:   Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0   [ Time Frame: At baseline (within 1 week before initiation of study therapy) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00306202     History of Changes
Other Study ID Numbers: CA180-018
Protocol ITCC 005
2005-002882-35 ( EudraCT Number )
First Submitted: March 21, 2006
First Posted: March 23, 2006
Results First Submitted: June 11, 2012
Results First Posted: July 23, 2012
Last Update Posted: September 26, 2017