A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
NCT ID: NCT03484520
Last Updated: 2022-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
48 participants
INTERVENTIONAL
2018-07-23
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Venetoclax + Dinaciclib
Venetoclax and dinaciclib will be administered in combination. Different combinations of dose levels for venetoclax and dinaciclib will be explored.
Venetoclax
tablet, oral
Dinaciclib
intravenous
Interventions
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Venetoclax
tablet, oral
Dinaciclib
intravenous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Countries
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Other Identifiers
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2017-003213-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M16-183
Identifier Type: -
Identifier Source: org_study_id