A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS
NCT ID: NCT04477291
Last Updated: 2025-03-07
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
45 participants
INTERVENTIONAL
2020-10-06
2024-04-15
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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Dose Escalation and Expansion
Dose Escalation and Expansion; CG-806 will be given orally in ascending doses in patients with relapsed or refractory AML or higher-risk MDS (escalation cohort), until the maximum tolerated dose or candidate recommended Phase 2 dose is reached. Followed up by up to 50 patients enrolled in the expansion cohort at the recommended dose.
CG-806
CG-806 will be given orally in ascending doses starting at 450 mg PO BID until the maximum tolerated dose or candidate recommended Phase 2 dose is reached.
Interventions
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CG-806
CG-806 will be given orally in ascending doses starting at 450 mg PO BID until the maximum tolerated dose or candidate recommended Phase 2 dose is reached.
Eligibility Criteria
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Inclusion Criteria
* Life expectancy of at least 3 months
* ECOG Performance Status ≤ 2
* Patients must be able to swallow capsules
* Adequate hematologic parameters, unless cytopenias are disease caused
* Adequate renal, liver and cardiac functions
Exclusion Criteria
* Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinically significant disease related metabolic disorder
* Clinically significant leukostasis
* Treatment with other investigational drugs or receipt of cytotoxic therapy within 14 days prior to first study treatment administration
* Receipt of cellular immunotherapeutic agents within 4 weeks prior to first study treatment administration
18 Years
ALL
No
Sponsors
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Aptose Biosciences Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rafael Bejar, MD, PhD
Role: STUDY_DIRECTOR
Aptose Biosciences Inc.
Locations
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City of Hope National Medical Center
Duarte, California, United States
University of Southern California
Los Angeles, California, United States
University of Miami
Miami, Florida, United States
Northwestern University
Chicago, Illinois, United States
Ochsner Healthcare
New Orleans, Louisiana, United States
Atlantic Hematological Oncology Center
Morristown, New Jersey, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University Hospital of Cleveland
Cleveland, Ohio, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Yu G, Zhang W, Basyal M, Nishida Y, Mizumo H, Ly C, Zhang H, Rice WG, Andreeff M. The multi-kinase inhibitor CG-806 exerts anti-cancer activity against acute myeloid leukemia by co-targeting FLT3, BTK, and aurora kinases. Leuk Lymphoma. 2024 Nov;65(11):1659-1674. doi: 10.1080/10428194.2024.2364839. Epub 2024 Jun 13.
Yu G, Zhang W, Zhang H, Ly C, Basyal M, Rice WG, Andreeff M. The multi-kinase inhibitor CG-806 exerts anti-cancer activity against acute myeloid leukemia by co-targeting FLT3, BTK, and Aurora kinases. Res Sq [Preprint]. 2023 Feb 22:rs.3.rs-2570204. doi: 10.21203/rs.3.rs-2570204/v1.
Other Identifiers
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APTO-CG-806-03
Identifier Type: -
Identifier Source: org_study_id
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