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Phase I Study of SRC/ABL Tyrosine Kinase Inhibitor Dasatinib [BMS-354825] in Children and Adolescents With Relapsed or Refractory Leukemia, Protocol ITCC 005

Phase 1
12 Months
20 Years
Open (Enrolling)

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Trial Information

Phase I Study of SRC/ABL Tyrosine Kinase Inhibitor Dasatinib [BMS-354825] in Children and Adolescents With Relapsed or Refractory Leukemia, Protocol ITCC 005

Inclusion Criteria:

- Ph-positive (Ph+) Chronic Myelogenous Leukemia in chronic, accelerated or blast phase
or Ph+ acute lymphoblastic leukemia (ALL) with imatinib-resistant disease or
intolerance to imatinib.

- Ph-negative acute leukemia in second or subsequent relapse

- Age >1 and <21 years

- Lansky or Karnofsky scale >60

- Life expectancy >3 weeks

- Adequate hepatic and renal function

- Written informed consent

Exclusion Criteria:

- Subjects for whom potentially-curative therapy was available, including electing
immediate [ie, planned <45 days] stem-cell transplantation. Subjects in Stratum 1
were to have had an ongoing identical HLA donor search, and may have discontinued
study if a donor became available.)

- Subjects with symptomatic central nervous system (CNS) disease (eg, convulsions due
to their CNS disease).

- Subjects who had not recovered from acute toxicity of previous therapy.

- Clinically-significant disorder of platelet function (eg, von Willebrand's disease)
or ongoing gastrointestinal bleeding.

- Serious uncontrolled medical disorder or active infection

- Uncontrolled or significant cardiovascular disease

- Use of any investigational agent or any other anticancer agent within 14 days prior
to treatment start.

- Prior therapy with dasatinib

- Subjects taking medications that irreversibly inhibit platelet function or

- Subjects taking certain medications that are accepted to have a risk of causing QTc

- Women of Child Bearing Potential with a positive pregnancy test prior to study drug

- Expected noncompliance, or unable to have regular follow-up due to psychologic,
social, familial, or geographic reasons.

- Subjects who are compulsorily detained for legal reasons or treatment of either a
psychiatric or physical (eg, infectious disease) illness must not be enrolled into
this study.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended Phase II Dose of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia

Outcome Description:

The recommended phase 2 dasatinib dose was determined based on efficacy, safety, and pharmacokinetic data obtained at the prespecified dose levels.

Outcome 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])

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

August 2018

Related Keywords:

  • Leukemia
  • Relapsed and Refractory Leukemia
  • Leukemia