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

Primary Purpose

Relapsed or Refractory Acute Myeloid Leukemia

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Tuspetinib
Venetoclax Oral Tablet
Sponsored by
Aptose Biosciences Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory Acute Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient is defined as having morphologically documented primary or secondary AML by the World Health Organization (WHO) criteria (2016) and fulfills one of the following:

    1. Refractory to at least 1 cycle of prior therapy
    2. Relapsed after achieving remission with a prior therapy
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Patient's interval from prior treatment to time of study drug administration is at least 2 weeks for cytotoxic agents (except hydroxyurea given for controlling blast cells), at 4 weeks for biologic or cellular immunotherapies, or at least 5 half-lives for prior experimental agents or noncytotoxic agents, including immunosuppressive therapy post hematopoietic stem cell transplantation (HSCT). (upon discussion with the Medical Monitor, shorter than stated washout period may be considered provided that the patient has recovered from any clinically relevant safety issue and recovered to Grade ≤ 1 toxicity from prior therapies)
  • Patient must meet the following criteria as indicated on the clinical laboratory tests

    1. Serum aspartate aminotransferase(AST) and alanine aminotransferase(ALT) ≤ 2.5× institutional upper limit normal (ULN)
    2. Total serum bilirubin ≤ 1.5× institutional ULN
    3. Serum creatinine ≤ 1.5× institutional ULN or an estimated glomerular filtration rate (eGFR) of > 45 ml/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation.
  • Patient is suitable for oral administration of study drug and has minimum life expectancy (≥ 3 months)
  • Female patient must be either:
  • Of non-child bearing potential

    1. Post-menopausal (defined as at least 1 year without any menses) prior to screening, or
    2. Documented surgically sterile or status post hysterectomy (at least 1 month prior to screening)
  • Or, if of childbearing potential,

    1. Must have a negative serum or urine pregnancy test at screening (within 72 hours prior to start of treatment), and
    2. Must use two forms of birth control£ (at least one of which must be a barrier method) starting at screening and throughout the study period and for 90 days after the final study drug administration.
  • Female patient must not be breastfeeding at screening and during the study period, and for 90 days after the final study drug administration
  • Female patient must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration.
  • Male patient and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control£ (one of which must be a barrier method) starting at screening and continue throughout the study period and for 90 days after the final study drug administration.
  • Male patient must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration.
  • Patient agrees not to participate in another interventional study while on treatment

Exclusion Criteria:

Patients must not enter the study if any of the following exclusion criteria are fulfilled.

  • Patient was diagnosed as acute promyelocytic leukemia (APL)
  • Patient has BCR-ABL-positive leukemia
  • Patient has an active malignancy other than AML, or Myelodysplastic Syndrome (MDS).
  • Patient has persistent non-hematological toxicities of ≥ Grade 2 (CTCAE v4.03), with symptoms and objective findings, from prior AML treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, or surgery)
  • Patient has had hematopoietic stem cell transplant (HSCT) and meets any of the following:

    1. Has undergone HSCT within the 2 month period prior to the first study dose
    2. Has clinically significant graft-versus-host-disease(GVHD) requiring treatment
    3. Has ≥ Grade 2 persistent non-hematological toxicity related to the transplant
    4. Donor lymphocytes infusion (DLI) is not permitted ≤ 30 days prior to the first study dose or during the first two cycle of treatment on the study.
  • Patient with symptomatic central nervous system (CNS) involvement of leukemia or other CNS diseases related to underlying and secondary effects of malignancy.
  • Patient has disseminated intravascular coagulation abnormality (DIC).
  • Patient has had major surgery within 4 weeks prior to the first study dose.
  • Patient has had radiation therapy within 4 weeks prior to the first study dose.
  • Patient has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patient with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 3 months prior to study entry results in a left ventricular ejection fraction (LVEF) that is ≥ 45%.
  • Any of the following cardiac abnormalities of history

    1. Patient has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval > 250milliseconds (ms).
    2. Patient has a mean QT interval (QTc) by Friderica's method (QTcF) > 450ms in three successive Screening measurements.
    3. Patient has any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as congenital long QT, syndrome, family history of long QT syndrome.
    4. Patient is unable or unwilling to discontinue concomitant use of drugs that are known to prolong the QT interval.
  • Patient is known to have active infection including any identified active COVID-19 infection.
  • Patient is known to have human immunodeficiency virus infection.
  • Patient has known active hepatitis B or C, or other active hepatic disorder.
  • Patient has any condition which, in the investigator's opinion, makes the patient unsuitable for study participation.

Sites / Locations

  • The Kirklin Clinic of UAB HospitalRecruiting
  • City of Hope Comprehensive Cancer CenterRecruiting
  • University of California IrvineRecruiting
  • UCSD Moores Cancer CenterRecruiting
  • USC/Norris Comprehensive Cancer CenterRecruiting
  • Stanford Cancer CenterRecruiting
  • University of California, DavisRecruiting
  • Yale UniversityRecruiting
  • University of Miami - Miller School of MedicineRecruiting
  • Emory UniversityRecruiting
  • Massachusetts General HospitalRecruiting
  • Duke University Medical CenterRecruiting
  • Cleveland Clinic - Taussig Cancer CenterRecruiting
  • The Ohio State University Wexner Medical CenterRecruiting
  • MD Anderson Cancer CenterRecruiting
  • Border Medical OncologyRecruiting
  • Townsville University HospitalRecruiting
  • St Vincent's Hospital MelbourneRecruiting
  • Kyungpook National University HospitalRecruiting
  • Pusan National University HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Seoul National University Hospital
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Auckland City HospitalRecruiting
  • Hospital Universitario Central de AsturiasRecruiting
  • Hospital Universitario Vall d'HebronRecruiting
  • Hospital Clinico Universitario de ValenciaRecruiting
  • Hospital Universitari i Politècnic La FeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Part A Dose Escalation

Part B Dose Exploration

Part C Dose Expansion (tuspetinib as a single agent)

Part C Dose Expansion (Combination Arm - tuspetinib and venetoclax)

Arm Description

For Part A (tuspetinib as a single agent), dose escalation cohort is planned up to 6 dose levels. If a subject in the dose escalation cohort at any dose level achieves clinical response then the dose level will continue to enroll in Part B. If one DLT or less is observed in the 6 patients (<1/6 DLT observed) in Part A, up to 20 evaluable patients can be enrolled in Part B at that dose level.

For Part B (tuspetinib as a single agent), dose exploration cohort is planned up to 4 dose levels.

Part C, dose expansion, consists of 2 arms (tuspetinib as a single agent or tuspetinib plus venetoclax). Patients will be randomly assigned to either arm based on the number of slots available. The initial tuspetinib dose for the single arm will be 120mg.

Part C, dose expansion, consists of 2 arms (tuspetinib or tuspetinib plus venetoclax). Patients will be randomly assigned to either arm based on the number of slots available. The initial tuspetinib dose for the combo arm will be 80mg.

Outcomes

Primary Outcome Measures

Recommended Phase 2 dose
To determine the recommended phase 2 dose based on safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) consideration
Safety of HM43239
Determine the maximum tolerated dose at which no more than 1 out of 6 patients experience a dose-limiting toxicity or establish the safety of clinically effective dose below the MTD if the MTD is not reached.relapsed or treatment-refractory (R/R) AML
Tolerability of HM43239
To determine the frequency and severity of drug-related adverse events across different dose levels when administered in patients with R/R AML
Safety of HM43239 in combination with venetoclax
Determine the maximum tolerated dose of HM43239 in combination with venetoclax at which no more than 1 out of 6 patients experience a dose-limiting toxicity or establish the safety of clinically effective dose below the MTD if the MTD is not reached.relapsed or treatment-refractory (R/R) AML
Tolerability of HM43239 in combination with venetoclax
To determine the frequency and severity of drug-related adverse events across different dose levels of HM43239 in combination with venetoclax when administered in patients with R/R AML

Secondary Outcome Measures

Anti-leukemic activity of HM43239
To investigate the rate of complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete platelet recovery (CRp), CR with incomplete hematologic recovery (CRi), and partial remission (PR) of patients taking HM43239
Anti-leukemic activity of HM43239 in combination with venetoclax
To investigate the rate of complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete platelet recovery (CRp), CR with incomplete hematologic recovery (CRi), and partial remission (PR) of patients taking HM43239 in combination with venetoclax
Pharmacokinetic variables including maximum plasma concentration (Cmax)
Pharmacokinetic variables including maximum plasma concentration (Cmax)
Pharmacokinetic variables including minimum plasma concentration (Cmin)
Pharmacokinetic variables including minimum plasma concentration (Cmin)
Pharmacokinetic variables including area under the curve (AUC)
Pharmacokinetic variables including area under the curve (AUC)
Pharmacokinetic variables including volume of distribution
Pharmacokinetic variables including volume of distribution
Pharmacokinetic variables including clearance
Pharmacokinetic variables including clearance
Pharmacodynamic variables
Determine PD variables by using a plasma inhibitory activity assay (PIA assay) examining the reduction in phospho-STAT5 and phospho-FLT3 in cell lines exposed to plasma from subjects treated in the study.

Full Information

First Posted
January 28, 2019
Last Updated
October 10, 2023
Sponsor
Aptose Biosciences Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03850574
Brief Title
Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Acronym
APTIVATE
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 Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aptose Biosciences Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Three parts in the study - Part A (dose escalation, tuspetinib as a single agent), Part B (dose exploration, tuspetinib as a single agent), Part C (dose expansion, tuspetinib as a single agent and combo arm of tuspetinib with venetoclax)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A Dose Escalation
Arm Type
Experimental
Arm Description
For Part A (tuspetinib as a single agent), dose escalation cohort is planned up to 6 dose levels. If a subject in the dose escalation cohort at any dose level achieves clinical response then the dose level will continue to enroll in Part B. If one DLT or less is observed in the 6 patients (<1/6 DLT observed) in Part A, up to 20 evaluable patients can be enrolled in Part B at that dose level.
Arm Title
Part B Dose Exploration
Arm Type
Experimental
Arm Description
For Part B (tuspetinib as a single agent), dose exploration cohort is planned up to 4 dose levels.
Arm Title
Part C Dose Expansion (tuspetinib as a single agent)
Arm Type
Experimental
Arm Description
Part C, dose expansion, consists of 2 arms (tuspetinib as a single agent or tuspetinib plus venetoclax). Patients will be randomly assigned to either arm based on the number of slots available. The initial tuspetinib dose for the single arm will be 120mg.
Arm Title
Part C Dose Expansion (Combination Arm - tuspetinib and venetoclax)
Arm Type
Experimental
Arm Description
Part C, dose expansion, consists of 2 arms (tuspetinib or tuspetinib plus venetoclax). Patients will be randomly assigned to either arm based on the number of slots available. The initial tuspetinib dose for the combo arm will be 80mg.
Intervention Type
Drug
Intervention Name(s)
Tuspetinib
Other Intervention Name(s)
HM43239
Intervention Description
Daily (QD), continuous dosing
Intervention Type
Drug
Intervention Name(s)
Venetoclax Oral Tablet
Other Intervention Name(s)
Venetoclax
Intervention Description
Venetoclax will be given to patients in combo treatment group (Part C) either in 50 mg or 100 mg tablets
Primary Outcome Measure Information:
Title
Recommended Phase 2 dose
Description
To determine the recommended phase 2 dose based on safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) consideration
Time Frame
4 years
Title
Safety of HM43239
Description
Determine the maximum tolerated dose at which no more than 1 out of 6 patients experience a dose-limiting toxicity or establish the safety of clinically effective dose below the MTD if the MTD is not reached.relapsed or treatment-refractory (R/R) AML
Time Frame
4 years
Title
Tolerability of HM43239
Description
To determine the frequency and severity of drug-related adverse events across different dose levels when administered in patients with R/R AML
Time Frame
4 years
Title
Safety of HM43239 in combination with venetoclax
Description
Determine the maximum tolerated dose of HM43239 in combination with venetoclax at which no more than 1 out of 6 patients experience a dose-limiting toxicity or establish the safety of clinically effective dose below the MTD if the MTD is not reached.relapsed or treatment-refractory (R/R) AML
Time Frame
4 years
Title
Tolerability of HM43239 in combination with venetoclax
Description
To determine the frequency and severity of drug-related adverse events across different dose levels of HM43239 in combination with venetoclax when administered in patients with R/R AML
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Anti-leukemic activity of HM43239
Description
To investigate the rate of complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete platelet recovery (CRp), CR with incomplete hematologic recovery (CRi), and partial remission (PR) of patients taking HM43239
Time Frame
4 years
Title
Anti-leukemic activity of HM43239 in combination with venetoclax
Description
To investigate the rate of complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete platelet recovery (CRp), CR with incomplete hematologic recovery (CRi), and partial remission (PR) of patients taking HM43239 in combination with venetoclax
Time Frame
4 years
Title
Pharmacokinetic variables including maximum plasma concentration (Cmax)
Description
Pharmacokinetic variables including maximum plasma concentration (Cmax)
Time Frame
Cycle 1 (at least 28 days)
Title
Pharmacokinetic variables including minimum plasma concentration (Cmin)
Description
Pharmacokinetic variables including minimum plasma concentration (Cmin)
Time Frame
Cycle 1 (at least 28 days)
Title
Pharmacokinetic variables including area under the curve (AUC)
Description
Pharmacokinetic variables including area under the curve (AUC)
Time Frame
Cycle 1 (at least 28 days)
Title
Pharmacokinetic variables including volume of distribution
Description
Pharmacokinetic variables including volume of distribution
Time Frame
Cycle 1 (at least 28 days)
Title
Pharmacokinetic variables including clearance
Description
Pharmacokinetic variables including clearance
Time Frame
Cycle 1 (at least 28 days)
Title
Pharmacodynamic variables
Description
Determine PD variables by using a plasma inhibitory activity assay (PIA assay) examining the reduction in phospho-STAT5 and phospho-FLT3 in cell lines exposed to plasma from subjects treated in the study.
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is defined as having morphologically documented primary or secondary AML by the World Health Organization (WHO) criteria (2016) and fulfills one of the following: Refractory to at least 1 cycle of prior therapy Relapsed after achieving remission with a prior therapy Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Patient's interval from prior treatment to time of study drug administration is at least 2 weeks for cytotoxic agents (except hydroxyurea given for controlling blast cells), at 4 weeks for biologic or cellular immunotherapies, or at least 5 half-lives for prior experimental agents or noncytotoxic agents, including immunosuppressive therapy post hematopoietic stem cell transplantation (HSCT). (upon discussion with the Medical Monitor, shorter than stated washout period may be considered provided that the patient has recovered from any clinically relevant safety issue and recovered to Grade ≤ 1 toxicity from prior therapies) Patient must meet the following criteria as indicated on the clinical laboratory tests Serum aspartate aminotransferase(AST) and alanine aminotransferase(ALT) ≤ 2.5× institutional upper limit normal (ULN) Total serum bilirubin ≤ 1.5× institutional ULN Serum creatinine ≤ 1.5× institutional ULN or an estimated glomerular filtration rate (eGFR) of > 45 ml/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation. Patient is suitable for oral administration of study drug and has minimum life expectancy (≥ 3 months) Female patient must be either: Of non-child bearing potential Post-menopausal (defined as at least 1 year without any menses) prior to screening, or Documented surgically sterile or status post hysterectomy (at least 1 month prior to screening) Or, if of childbearing potential, Must have a negative serum or urine pregnancy test at screening (within 72 hours prior to start of treatment), and Must use highly effective contraception starting at screening and throughout the study period and for 90 days after the final study drug administration. Female patient must not be breastfeeding at screening and during the study period, and for 90 days after the final study drug administration Female patient must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration. Male patient and their female spouse/partners who are of childbearing potential must be using highly effective contraception starting at screening and continue throughout the study period and for 90 days after the final study drug administration. Male patient must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration. Patient agrees not to participate in another interventional study while on treatment Exclusion Criteria: Patients must not enter the study if any of the following exclusion criteria are fulfilled. Patient was diagnosed as acute promyelocytic leukemia (APL) Patient has BCR-ABL-positive leukemia Patient has an active malignancy other than AML, or Myelodysplastic Syndrome (MDS). Patient has persistent non-hematological toxicities of ≥ Grade 2 (CTCAE v4.03), with symptoms and objective findings, from prior AML treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, or surgery) Patient has had hematopoietic stem cell transplant (HSCT) and meets any of the following: Has undergone HSCT within the 2 month period prior to the first study dose Has clinically significant graft-versus-host-disease(GVHD) requiring treatment Has ≥ Grade 2 persistent non-hematological toxicity related to the transplant Has a donor lymphocytes infusion (DLI) ≤ 30 days prior to the first study dose or during the first two cycle of treatment on the study. Patient has meningeal or central nervous system (CNS) involvement with leukemia or other CNS disease related to underlying and secondary effects of malignancy. Patient has disseminated intravascular coagulation abnormality (DIC). Patient has had major surgery within 4 weeks prior to the first study dose. Patient has had radiation therapy within 4 weeks prior to the first study dose. Patient has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patient with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 3 months prior to study entry results in a left ventricular ejection fraction (LVEF) that is ≥ 45%. Any of the following cardiac abnormalities of history Patient has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval > 250 milliseconds (ms). Patient has a mean QT interval (QTc) by Friderica's method (QTcF) > 450ms in three successive Screening measurements. Patient has any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as congenital long QT, syndrome, family history of long QT syndrome. Patient is unable or unwilling to discontinue concomitant use of drugs that are known to prolong the QT interval. Patient is known to have active infection including any identified active COVID-19 infection. Patient is known to have human immunodeficiency virus infection. Patient has known active hepatitis B or C, or other active hepatic disorder. Patient has any condition which, in the investigator's opinion, makes the patient unsuitable for study participation. Patient has a history of Grade 3 or 4 non-hematologic toxicity related to tyrosine kinase inhibitor.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafael Bejar, MD, PhD
Phone
858-401-6852
Email
rbejar@aptose.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naval Daver, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Kirklin Clinic of UAB Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pankit Vachhani, MD
Email
jsregister@uabmc.edu
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Koller, MD
Phone
626-222-4727
Email
pkoller@coh.org
Facility Name
University of California Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deepa Jeyakumar, MD
Email
djeyakum@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Deepa Jeyakumar, MD
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn Mulroney, MD
Email
camulroney@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Carolyn Mulroney, MD
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Tam, MD
Email
eric.tam@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Eric Tam, MD
Facility Name
Stanford Cancer Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel Mannis, MD
Email
gmannis@stanford.edu
First Name & Middle Initial & Last Name & Degree
Gabriel Mannis, MD
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Jonas
Phone
916-703-9151
Email
bajonas@ucdavis.edu
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolai Podoltsev, MD
Email
nikolai.podoltsev@yale.edu
First Name & Middle Initial & Last Name & Degree
Nikolai Podoltsev, MD, PhD
Facility Name
University of Miami - Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Watts, MD
Email
jxw401@miami.edu
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martha Arellano
Phone
404-712-0720
Email
marella@emory.edu
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Fathi, MD
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harry Erba, MD
Email
harry.erba@duke.edu
Facility Name
Cleveland Clinic - Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Studipto Mukherjee, MD
Email
mukhers2@ccf.org
First Name & Middle Initial & Last Name & Degree
Studipto Mukherjee, MD
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uma Borate, MD
Email
uma.borate@osumc.edu
First Name & Middle Initial & Last Name & Degree
Uma Borate, MD
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naval Daver, Dr
Phone
713-792-6477
Email
NDaver@mdanderson.org
Facility Name
Border Medical Oncology
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anish Puliyayil, MD
Email
apuliyayil@bordermedonc.com.au
First Name & Middle Initial & Last Name & Degree
Anish Puliyayil, MD
Facility Name
Townsville University Hospital
City
Townsville
State/Province
Queensland
ZIP/Postal Code
4812
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hock-Choong Lai, MD
Email
Hock.lai@health.qld.gov.au
First Name & Middle Initial & Last Name & Degree
Hock-Choong Lai, MD
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuhying Tan, MD
Email
ShuhYing.TAN@svha.org.au
First Name & Middle Initial & Last Name & Degree
Shuhying Tan, MD
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-Kyun Sohn
Facility Name
Pusan National University Hospital
City
Pusan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho-Jin Shin
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong-Ok Lee
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Terminated
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunksuk Choi, MD
Phone
+82-2-3010-3292
Email
choiysmd@gmail.com
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chul-Won Jung
Phone
+82-2-3410-2980
Email
chulwon1.jung@samsung.com
Facility Name
Auckland City Hospital
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leanne Berkahn, MD
Email
LeanneBerk@adhb.govt.nz
First Name & Middle Initial & Last Name & Degree
Leanna Berkahn, MD
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Bernal
Email
bernaldelcastillo@gmail.com
First Name & Middle Initial & Last Name & Degree
Teresa Bernal
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Salamero, MD
Email
osalamero@vhio.net
First Name & Middle Initial & Last Name & Degree
Olga Salamero
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Tormo, MD
Email
tormo_mar@gva.es
First Name & Middle Initial & Last Name & Degree
Maria Tormo, MD
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pau Montesinos, MD
Email
montesinos_pau@gva.es
First Name & Middle Initial & Last Name & Degree
Pau Montesinos, MD

12. IPD Sharing Statement

Learn more about this trial

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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