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

Stopped early · Phase 1

Conditions studied: Cancer - Acute Myeloid Leukemia

In brief

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).

Key facts

Study ID

NCT03484520

Run by

AbbVie

People needed

48

Starts

2018-07-23

Expected to finish

2022-12-01

Last updated by the study team

2022-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Arkansas /ID# 200016 — Little Rock, Arkansas, United States
• David Geffen School of Medicin /ID# 200015 — Los Angeles, California, United States
• The University ofChicago /ID# 200017 — Chicago, Illinois, United States
• University of Maryland School of Medicine /ID# 204015 — Baltimore, Maryland, United States
• Wake Forest Baptist Medical Center /ID# 200288 — Winston-Salem, North Carolina, United States
• The Ohio State University /ID# 200668 — Columbus, Ohio, United States
• University of Texas MD Anderson Cancer Center /ID# 205215 — Houston, Texas, United States
• Gold coast University Hospital /ID# 202759 — Southport, Queensland, Australia
• Royal Hobart Hospital /ID# 202763 — Hobart, Tasmania, Australia
• Monash Medical Centre /ID# 202762 — Melbourne, Victoria, Australia
• Hospital Universitario Ramon y Cajal /ID# 201729 — Madrid, Spain
• Hospital Universitario de Salamanca /ID# 201728 — Salamanca, Spain
• Hospital Universitario y Politecnico La Fe /ID# 202318 — Valencia, Spain

Full record on ClinicalTrials.gov

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