Status:
TERMINATED
A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Lead Sponsor:
AbbVie
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Cancer - Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 pati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03484520
Start Date
July 23 2018
End Date
December 1 2022
Last Update
December 30 2022
Active Locations (13)
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1
University of Arkansas /ID# 200016
Little Rock, Arkansas, United States, 72205
2
David Geffen School of Medicin /ID# 200015
Los Angeles, California, United States, 90095
3
The University ofChicago /ID# 200017
Chicago, Illinois, United States, 60637
4
University of Maryland School of Medicine /ID# 204015
Baltimore, Maryland, United States, 21201-1544