Spots Global Cancer Trial Database for A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS
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Trial Identification
Brief Title: A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS
Official Title: A Phase 1a/b Trial of CG-806 in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndromes
Study ID: NCT04477291
Interventions
Study Description
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, therapy-related AML, or higher-risk MDS, whose disease has relapsed, is refractory or who are ineligible for or intolerant of intensive chemotherapy or transplantation.
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 dose in patients with relapsed or refractory Acute Myeloid Leukemia (except APML), secondary AML, therapy-related AML, or higher-risk MDS whose disease has relapsed, is refractory or who are ineligible for or intolerant of intensive chemotherapy or transplantation. This is to be followed by a cohort expansion phase.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Rafael Bejar, MD, PhD
Affiliation: Aptose Biosciences Inc.
Role: STUDY_DIRECTOR
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