Study of the ZN-d5 and ZN-c3 in Subjects With Acute Myeloid Leukemia (AML)
NCT ID: NCT05682170
Last Updated: 2024-09-19
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/PHASE2
40 participants
INTERVENTIONAL
2022-12-01
2024-07-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Acute Myeloid Leukemia
Phase 1: Dose Escalation- c3 monotherapy and d5+c3 combination
Phase 2: Dose Expansion
ZN-d5 ZN-c3
Oral agent
ZN-c3
Oral agent
Interventions
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ZN-d5 ZN-c3
Oral agent
ZN-c3
Oral agent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG performance status score ≤2.
* Projected life expectancy of at least 12 weeks.
* Estimated glomerular filtration rate ≥60 mL/min
* Women of childbearing potential must not be pregnant and must use effective birth control during the study and for 6 months after the last dose of study drugs.
* Men must agree to use a condom when having intercourse during the study and for 3 months after the last dose of study drugs.
Exclusion Criteria
* Diagnosis of acute promyelocytic leukemia.
* Peripheral blast count of \>25 × 109/L (cytoreduction permitted).
* Adequate washout from prior therapy including hematopoietic stem cell transplant and recovery from prior treatment-related toxicities to Grade 2 or lower
* Significant cardiovascular disease
* Corrected QT interval (QTc) of \>480 msec
* Active hepatitis B or hepatitis C infection
* Concurrent treatment with strong CYP3A inhibitors or strong or moderate CYP3A inducers
18 Years
ALL
No
Sponsors
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K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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K-Group Alpha, Inc. a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
K-Group Alpha
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California San Francisco
San Francisco, California, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Albert Einstein College of Medicine - Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Tristar Bone Marrow Transplant
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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ZN-d5-004C
Identifier Type: -
Identifier Source: org_study_id
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