Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

March 11, 2019

Primary Completion Date

November 30, 2026

Study Completion Date

April 30, 2027

Conditions
Leukemia, Myeloid, AcuteRefractory AMLRelapsed Adult AMLMyelodysplastic Syndrome With Excess Blasts-2Chronic Myelomonocytic Leukemia
Interventions
DRUG

Tuspetinib

Daily (QD), continuous dosing

DRUG

Venetoclax Oral Tablet

Venetoclax will be given to study participants in the Part C tuspetinib plus venetoclax combination treatment group either in 50 mg or 100 mg tablets

DRUG

Azacitidine for Intravenous Infusion

Azacitidine will be given to study participants in Part D as intravenous infusion at a dose of 75 mg/m\^2

Trial Locations (34)

1023

ACTIVE_NOT_RECRUITING

Auckland City Hospital, Grafton

2640

ACTIVE_NOT_RECRUITING

Border Medical Oncology, Albury

3065

ACTIVE_NOT_RECRUITING

St Vincent's Hospital Melbourne, Fitzroy

4006

ACTIVE_NOT_RECRUITING

Royal Brisbane and Women's Hospital, Herston

4812

ACTIVE_NOT_RECRUITING

Townsville University Hospital, Townsville

6009

ACTIVE_NOT_RECRUITING

Sir Charles Gairdner Hospital, Nedlands

13353

ACTIVE_NOT_RECRUITING

Charité Universitätsmedizin Berlin, Berlin

13620

ACTIVE_NOT_RECRUITING

Seoul National University Bundang Hospital, Seongnam

27705

RECRUITING

Duke University Medical Center, Durham

28223

ACTIVE_NOT_RECRUITING

Hospital Quirón Madrid, Pozuelo de Alarcón

30322

ACTIVE_NOT_RECRUITING

Emory University, Atlanta

33011

ACTIVE_NOT_RECRUITING

Hospital Universitario Central de Asturias, Oviedo

33136

RECRUITING

University of Miami - Miller School of Medicine, Miami

35233

RECRUITING

The Kirklin Clinic of UAB Hospital, Birmingham

41944

ACTIVE_NOT_RECRUITING

Kyungpook National University Hospital, Daegu

43210

RECRUITING

The Ohio State University Wexner Medical Center, Columbus

44106

ACTIVE_NOT_RECRUITING

Cleveland Clinic - Taussig Cancer Center, Cleveland

46010

ACTIVE_NOT_RECRUITING

Hospital Clinico Universitario de Valencia, Valencia

46026

ACTIVE_NOT_RECRUITING

Hospital Universitari i Politècnic La Fe, Valencia

49241

ACTIVE_NOT_RECRUITING

Pusan National University Hospital, Pusan

77030

RECRUITING

MD Anderson Cancer Center, Huston

90033

RECRUITING

USC/Norris Comprehensive Cancer Center, Los Angeles

91010

ACTIVE_NOT_RECRUITING

City of Hope Comprehensive Cancer Center, Duarte

92093

ACTIVE_NOT_RECRUITING

UCSD Moores Cancer Center, La Jolla

92697

RECRUITING

University of California Irvine, Irvine

94304

RECRUITING

Stanford Cancer Center, Palo Alto

95817

RECRUITING

University of California, Davis, Sacramento

06520

RECRUITING

Yale University, New Haven

02114

ACTIVE_NOT_RECRUITING

Massachusetts General Hospital, Boston

04103

ACTIVE_NOT_RECRUITING

Universitätsklinikum Leipzig, Leipzig

03080

COMPLETED

Seoul National University Hospital, Seoul

05505

ACTIVE_NOT_RECRUITING

Asan Medical Center, Seoul

06351

ACTIVE_NOT_RECRUITING

Samsung Medical Center, Seoul

08035

ACTIVE_NOT_RECRUITING

Hospital Universitario Vall d'Hebron, Barcelona

Sponsors
All Listed Sponsors
lead

Aptose Biosciences Inc.

INDUSTRY

NCT03850574 - Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter