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

AbbVie

Status and phase

Terminated

Phase 1

Conditions

Cancer - Acute Myeloid Leukemia

Treatments

Drug: Dinaciclib

Drug: Venetoclax

Study type

Interventional

Funder types

Industry

Identifiers

NCT03484520

M16-183

2017-003213-26 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.