NCT02003573

Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML)

An Open Label, Phase I, Dose Escalation Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Volasertib in Combination With Decitabine in Patients >= 65 Years With Acute Myeloid Leukemia

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Dose Escalation (MTD Finding) Phase: To investigate the maximum tolerated dose (MTD), safety and pharmacokinetics of different volasertib administration schedules in combination with decitabine in previously untreated AML patients \>= 65 years of age who are considered ineligible for standard intensive therapy, or patients with relapsed or refractory AML regardless of prior treatment status. MTD Extension Phase: To collect additional data on safety, efficacy and pharmacokinetics of volasertib in combination with decitabine in previously untreated patients with AML \>= 65 years of age and considered ineligible for standard intensive therapy.

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
DRUG	decitabine iv	decitabine iv fixed dose
DRUG	volasertib iv infusion	volasertib iv infusion (Body Surface Area (BSA) based dosing)

Timeline

• Start date: 2014-01-29
• Primary completion: 2015-01-06
• Completion: 2016-05-15
• First posted: 2013-12-06
• Last updated: 2019-01-31
• Results posted: 2019-01-31

Locations

3 sites across 1 country: United States