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

PHASE1CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

May 31, 2011

Study Completion Date

May 22, 2019

Conditions
Leukemia
Interventions
DRUG

Dasatinib

"Tablets, Oral, If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). 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.~Intra-participant dose escalation was allowed based on tolerance and on individual response. The starting dose for subsequent participants in a stratum may have been escalated depending on safety, assessed by prior intra-participant dose-escalation, and lack of efficacy in previous participants. Treatment courses were defined as 3 weeks (21 days plus any required delay); for participants who stayed on treatment \> 12 months, courses after 12 months were defined in quartiles of 13 weeks. Participants were to be followed until death or up to 5 years after end-of-treatment (EOT)."

DRUG

Dasatinib

"Tablets, Oral, If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). 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.~Intra-participant dose escalation was allowed based on tolerance and on individual response. The starting dose for subsequent participants in a stratum may have been escalated depending on safety, assessed by prior intra-participant dose-escalation, and lack of efficacy in previous participants. Treatment courses were defined as 3 weeks (21 days plus any required delay); for participants who stayed on treatment \> 12 months, courses after 12 months were defined in quartiles of 13 weeks. Participants were to be followed until death or up to 5 years after EOT."

DRUG

Dasatinib

"Tablets, Oral, If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). 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.~Intra-participant dose escalation was allowed based on tolerance and on individual response. The starting dose for subsequent participants in a stratum may have been escalated depending on safety, assessed by prior intra-participant dose-escalation, and lack of efficacy in previous participants. Treatment courses were defined as 3 weeks (21 days plus any required delay); for participants who stayed on treatment \> 12 months, courses after 12 months were defined in quartiles of 13 weeks. Participants were to be followed until death or up to 5 years after EOT."

Trial Locations (13)

1090

Local Institution, Vienna

13353

Local Institution, Berlin

20052

Local Institution, Monza (mi)

30625

Local Institution, Hanover

44093

Local Institution, Nantes

60590

Local Institution, Frankfurt

75475

Local Institution, Paris

75571

Local Institution, Paris

3015 GJ

Local Institution, Rotterdam

M27 4HA

Local Institution, Manchester

BS2 8BJ

Local Institution, Bristol

SM2 5PT

Local Institution, Sutton

B4 6NH

Local Institution, Birmingham

Sponsors
All Listed Sponsors
collaborator

Innovative Therapies For Children with Cancer Consortium

OTHER

lead

Bristol-Myers Squibb

INDUSTRY