Spots Global Cancer Trial Database for Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)
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Trial Identification
Brief Title: Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)
Official Title: A Single-Arm, Open-Label Pharmacokinetic, Safety, and Efficacy Study of ASTX727 in Combination With Venetoclax in Adult Patients With Acute Myeloid Leukemia
Study ID: NCT04657081
Conditions
Study Description
Brief Summary: The Phase 1 portion of this study is a single-arm, open-label, multicenter, non-randomized interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and efficacy of ASTX727 when given in combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. The primary purpose of the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination therapy by evaluating area under the curve (AUC) and maximum plasma concentration (Cmax) exposure. The Phase 2 portion of the study is to assess the efficacy of ASTX727 and venetoclax when given in combination and to evaluate potential PK interactions. Phase 2 will follow the same overall study design as Phase 1 and has two parts, Part A and Part B.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
Stanford University, Palo Alto, California, United States
Yale University, New Haven, Connecticut, United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
Boca Raton Clinical Research, Plantation, Florida, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
Indiana University Simon Cancer Center, Indianapolis, Indiana, United States
Tufts Medical Center, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
University of Massachusetts, Memorial Medical Center, Worcester, Massachusetts, United States
Health Midwest Ventures Group, Inc., Kansas City, Missouri, United States
Hackensack University of Medical Center, Hackensack, New Jersey, United States
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
Weill Cornell Medical College, New York, New York, United States
University of Rochester, Rochester, New York, United States
The Research Foundation of the State University of New York (SUNY), Syracuse, New York, United States
East Carolina University, Greenville, North Carolina, United States
The Ohio State University, Columbus, Ohio, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Baylor Scott & White Research Institute, Temple, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Calgary - Health Sciences Centre, Calgary, Alberta, Canada
University of Alberta, Edmonton, Alberta, Canada
The Ottawa Hospital, General Campus, Ottawa, Ontario, Canada
Jewish General Hospital, Montréal, , Canada
Hospital Universitario Central de Asturias, Oviedo, Austrias, Spain
Institut Catala d'Oncologia-Hospital Duran i Reynals, L'Hospitalet De Llobregat, Barcelona, Spain
Clinica Universidad de Navarra, Pamplona, Pamplona, Navarra, Spain
Universitario Gregorio Marañon, Madrid, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain
Contact Details
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