drugset / Trial / NCT02527174
A Study of Volasertib Plus Induction Chemotherapy for Acute Myeloid Leukemia
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase I clinical trial to determine the maximum tolerated dose (MTD) of the polo-like kinase-1 inhibitor volasertib which can be safely combined with idarubicin plus cytarabine induction chemotherapy for previously untreated patients with acute myeloid leukemia. (AML).
Timeline
- Start
- 2016-11
- Primary completion
- 2018-05
- Completion
- 2018-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Volasertib | Small molecule | 140 mg/m2 | Intravenous |
| Subject | Volasertib | Small molecule | 170 mg/m2 | Intravenous |
| Subject | Volasertib | Small molecule | 200 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 100 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 200 mg/m2 | Intravenous |
| Background | Idarubicin | Small molecule | 12 mg/m2 | Intravenous |