Spots Global Cancer Trial Database for Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia
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Trial Identification
Brief Title: Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Official Title: A Phase 1/2 Open Label, Multicenter, Dose Escalation and Expansion Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM43239 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Study ID: NCT03850574
Study Description
Brief Summary: A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Tuspetinib (HM43239) in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
Detailed Description: This is a Phase 1/2, open-label, multi-center study to assess the efficacy, safety, tolerability, pharmacokinetics, including recommended phase 2 dose (RP2D) of tuspetinib (HM43239) monotherapy in subjects with relapsed or treatment-refractory acute myeloid leukemia (AML). This study will also evaluate the safety, tolerability, and PK parameters of tuspetinib (HM43239) in combination with venetoclax when administered in patients with R/R AML
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Kirklin Clinic of UAB Hospital, Birmingham, Alabama, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
University of California Irvine, Irvine, California, United States
UCSD Moores Cancer Center, La Jolla, California, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Stanford Cancer Center, Palo Alto, California, United States
University of California, Davis, Sacramento, California, United States
Yale University, New Haven, Connecticut, United States
University of Miami - Miller School of Medicine, Miami, Florida, United States
Emory University, Atlanta, Georgia, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Duke University Medical Center, Durham, North Carolina, United States
Cleveland Clinic - Taussig Cancer Center, Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
MD Anderson Cancer Center, Houston, Texas, United States
Border Medical Oncology, Albury, New South Wales, Australia
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
Townsville University Hospital, Townsville, Queensland, Australia
St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Universitätsklinikum Leipzig, Leipzig, Saxony, Germany
Charité Universitätsmedizin Berlin, Berlin, , Germany
Kyungpook National University Hospital, Daegu, , Korea, Republic of
Pusan National University Hospital, Pusan, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Auckland City Hospital, Grafton, Auckland, New Zealand
Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
Hospital Quirón Madrid, Pozuelo De Alarcón, Madrid, Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain
Contact Details
Name: Naval Daver, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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