NCT00866281 - A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions

Acute Myeloid LeukemiaAcute Lymphoblastic Leukemia

Interventions

DRUG

midostaurin

Midostaurin 25 mg/mL oral solution was provided in bottles of 50 mL, administered with water. The pediatric starting dose of midostaurin was set at 30 mg/m2 bid and was not to exceed 60 mg/m2 bid.

Trial Locations (8)

10126

Novartis Investigative Site, Torino

16147

Novartis Investigative Site, Genova

20900

Novartis Investigative Site, Monza

75935

Novartis Investigative Site, Paris

98105

Seattle Children's Hospital CPKC412A2114, Seattle

00165

Novartis Investigative Site, Roma

3015 GJ

Novartis Investigative Site, Rotterdam

SE-171 76

Novartis Investigative Site, Stockholm