Status:
TERMINATED
A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS
Lead Sponsor:
Aptose Biosciences Inc.
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is being done to evaluate the safety, tolerability and antitumor activity of oral CG-806 (luxeptinib) for the treatment of patients with Acute Myeloid Leukemia (except APML), secondary AML,...
Detailed Description
This is a multicenter, open-label, Phase 1 a/b dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the MTD or recommended d...
Eligibility Criteria
Inclusion
- Key
- Age ≥18 years
- 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
- Key
Exclusion
- Patients with GVHD requiring systemic immunosuppressive therapy
- 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
Key Trial Info
Start Date :
October 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04477291
Start Date
October 6 2020
End Date
April 15 2024
Last Update
March 7 2025
Active Locations (10)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
University of Southern California
Los Angeles, California, United States, 90033
3
University of Miami
Miami, Florida, United States, 33136
4
Northwestern University
Chicago, Illinois, United States, 60611