Study of BMS-354825 in Children and Adolescents With Relapsed or Refractory Leukemia - Full Text View

Sponsors and Collaborators:	Bristol-Myers Squibb ITCC
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00306202

Purpose

The purpose of this clinical research study is to find out if dasatinib [BMS-354825] is effective for relapsed or refractory (resistant to previous treatment) leukemia in children and teenagers. The side effects this oral investigational drug may have in children, and the levels of the drug in the blood, will be studied at different doses.

Condition	Intervention	Phase
Leukemia	Drug: Dasatinib	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase I/II Study of Src/Abl Tyrosine Kinase Inhibitor Dasatinib [BMS-354825] in Children and Adolescents With Relapsed or Refractory Leukemia, Protocol ITCC 005

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Dasatinib

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To establish by stratum, using a dose-finding design, a recommended Phase II dose of dasatinib in children and adolescents with relapsed or refractory leukemia [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine the adverse events (AEs) and identify dose-limiting toxicities of dasatinib in children and adolescents with chronic myelogenous leukemia (CML) in chronic phase (stratum 1) or advanced leukemias (strata 2/3-4, aggregated) [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
To estimate by stratum, the rates of morphologic, cytogenetic, and molecular response to dasatinib [ Time Frame: at the end of study ] [ Designated as safety issue: No ]
To estimate, as a function of dasatinib dose, plasma and cerebrospinal fluid pharmacokinetic parameters of dasatinib [ Time Frame: at end of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	59
Study Start Date:	March 2006
Estimated Study Completion Date:	August 2018
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: Dasatinib Tablets, Oral, Starting Dose Level of 60mg/m2; escalation of starting dose and intrapatient dose-escalation foreseen per protocol. Dose levels: 60, 80, 100, 120, and 150 mg/m2. once daily, up to 2 years, as long as clinical benefit is maintained

Eligibility

Ages Eligible for Study:	12 Months to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Philadelphia chromosome positive (Ph+) CML in chronic, accelerated or blast phase or Ph+ acute lymphocytic leukemia (ALL) with imatinib-resistant disease or intolerance
Ph-negative acute leukemias in second or subsequent relapse
Age >= 1 and < 21 years
Lansky or Karnofsky scale >= 60
Adequate hepatic and renal function

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306202

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations

Austria
Local Institution	Recruiting
Vienna, Austria, 1090
Contact: Site 001
Belgium
Local Institution	Recruiting
Gent, Belgium, 9000
Contact: Site 014
France
Local Institution	Recruiting
Paris Cedex 10, France, 75475
Contact: Site 002
Local Institution	Recruiting
Paris Cedex 12, France, 75571
Contact: Site 009
Local Institution	Recruiting
Nantes, France, 44093
Contact: Site 012
Local Institution	Recruiting
Lyon, France, 69008
Contact: Site 015
Germany
Local Institution	Recruiting
Berlin, Germany, 13353
Contact: Site 003
Local Institution	Recruiting
Hannover, Germany, 30625
Contact: Site 004
Local Institution	Recruiting
Frankfurt, Germany, 60590
Contact: Site 011
Italy
Local Institution	Recruiting
Monza (Mi), Italy, 20052
Contact: Site 005
Local Institution	Recruiting
Padova, Italy, 35128
Contact: Site 016
Netherlands
Local Institution	Recruiting
Rotterdam, Netherlands, 3015 GJ
Contact: Site 006
United Kingdom, Surrey
Local Institution	Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Site 010
United Kingdom, West Midlands
Local Institution	Recruiting
Birmingham, West Midlands, United Kingdom, B4 6NH
Contact: Site 013

Sponsors and Collaborators

Bristol-Myers Squibb

ITCC

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA180-018, Protocol ITCC 005
Study First Received:	March 21, 2006
Last Updated:	September 2, 2009
ClinicalTrials.gov Identifier:	NCT00306202 History of Changes
Health Authority:	United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency

Keywords provided by Bristol-Myers Squibb:

Relapsed and Refractory Leukemia

Study placed in the following topic categories:

Leukemia
Dasatinib
Tyrosine
Protein Kinase Inhibitors

Additional relevant MeSH terms:

Leukemia
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action

Dasatinib
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009