A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Phase 1b Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia

An open-label, dose-escalation study to assess safety, pharmacokinetics and efficacy as well as determine the recommended Phase 2 doses of co-administered therapy of dinaciclib and venetoclax for patients with relapsed or refractory Acute Myeloid Leukemia (R/R AML).

Inclusion Criteria:

• Diagnosis of acute myeloid leukemia (AML) by World Health Organization criteria excluding acute promyelocytic leukemia (APL)-M3.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.

Exclusion Criteria:

• Known central nervous system leukemia
• Severe chronic obstructive pulmonary disease (COPD) with hypoxemia
• History of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment.
• Prior allogeneic stem cell transplant within 6 months of study drug administration and no requirement for graft versus host therapy.
• History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study.
• Known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
• History of tumor lysis syndrome (TLS) due to previous exposure to venetoclax.