Conditions: Myelodysplastic Syndromes Leukemia, Myelomonocytic, Chronic
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 5
Healthy volunteers: no

Brief summary:
To identify the maximum tolerated dose or recommended dose for further development of volasertib in combination with azacitidine in Japanese patients with myelodysplastic syndromes or chronic myelomonocytic leukemia, and evaluate the safety and tolerability, pharmacokinetics and the preliminary efficacy of this combination.

Detailed description:

Arms:
arm 1: Volasertib escalating doses + azacitidine

Interventions: intervention 1: Azacitidine intervention 2: Volasertib
Intervention descriptions: intervention 1: Azacitidine (subcutaneous) intervention 2: Volasertib escalating doses (intravenous)

Protocol document: