Conditions: Leukemia, Myeloid, Acute
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 68
Healthy volunteers: no

Brief summary:
Investigation of maximum tolerated dose, safety, efficacy and pharmcokinetics of BI 811283 in combination with cytarabine (LD-Ara-C) in previously untreated acute myeloid leukaemia (AML) patients

Detailed description:

Arms:
arm 1: BI 811283 on days 1 and 15 in combination with Cytarabine 20 mg twice daily on Days 1-10 arm 2: BI 811283 on Day 1 in combination with Cytarabine 20 mg twice daily on Days 1-10

Interventions: intervention 1: BI 811283 (d 1 and 15) intervention 2: Cytarabine intervention 3: BI 811283 (d1) intervention 4: Cytarabine
Intervention descriptions: intervention 1: BI 811283 (24 hours i.v.c.i.) on day 1 and 15 of a 4-week treatment cycle intervention 2: Cytarabine 2 x 20 mg/d s.c. on days 1-10 of a 4-week treatment cycle intervention 3: BI 811283 (24 hours i.v.c.i.) on day 1 of a 4-week treatment cycle intervention 4: Cytarabine 2 x 20 mg/d s.c. on days 1-10 of a 4-week treatment cycle

Protocol document: