An Open-label, Phase I/II Trial to Determine the Maximum Tolerated Dose and Investigate Safety, Pharmacokinetics and Efficacy of BI 836858 in Combination With Decitabine in Patients With Acute Myeloid Leukemia
An Open-label, Phase I/II Trial to Determine the Maximum Tolerated Dose and Investigate Safety, Pharmacokinetics and Efficacy of BI 836858 in Combination With Decitabine in Patients With Acute Myeloid Leukemia
Phase I Dose Escalation:
Primary objective is to determine the Maximum Tolerated Dose (MTD) and the recommended dose for Phase I Extension.
Secondary objective is to investigate the safety, pharmacokinetics and efficacy of BI 836858 in combination with decitabine
Phase I Extension:
Primary objective is to collect additional data on safety, pharmacokinetics and efficacy and to define the Recommended Phase II Dose (RP2D) of BI 836858 in combination with decitabine.
Phase II: Primary objective is to investigate efficacy, safety and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy.
Inclusion criteria:
1)
Phase I Dose Escalation:
Phase I Extension and Phase II:
-- Male or female patients >/= 65 years of age with previously untreated AML ineligible for receiving standard intensive therapy
2) Histologically or cytologically confirmed AML according to the WHO classification 3) Patients must be eligible for treatment with decitabine 4) Eastern co-operative oncology group (ECOG) performance score </=2 at screening Further inclusion criteria apply.
Exclusion criteria:
Acute promyelocytic leukemia (APL, French-American-British (FAB) subtype M3), according to WHO classification.
Patients who are candidates for allogeneic stem cell transplantation.
Active chronic graft versus host disease requiring immunosuppressive treatment.
Phase I extension and Phase II only:
Prior treatment with a hypomethylating agent, such as prior treatment for Myelodysplastic Syndrome (MDS).
Prior treatment with Cluster of differentiation 33 (CD33) antibody. Further exclusion criteria apply.