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Tyrosine Kinase Inhibitor
Tuspetinib + Venetoclax for Acute Myeloid Leukemia(APTIVATE Trial)
Phase 1 & 2
Recruiting
Led By Naval Daver, MD
Research Sponsored by Hanmi Pharmaceutical Company Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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:
Patient must meet the following criteria as indicated on the clinical laboratory tests
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up4 years
Awards & highlights
No Placebo-Only Group
APTIVATE Trial Summary
This trial is testing a new drug, HM43239, for patients with relapsed or refractory acute myeloid leukemia (AML). The goal is to find the safe dose range and to see how well the drug works.
Eligible Conditions
- Acute Myeloid Leukemia
APTIVATE Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have already tried at least one cycle of treatment, but it did not work for you.
Select...
You have had a relapse after getting better with a previous treatment.
APTIVATE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended Phase 2 dose
Safety of HM43239
Safety of HM43239 in combination with venetoclax
+2 moreSecondary outcome measures
Anti-leukemic activity of HM43239
Anti-leukemic activity of HM43239 in combination with venetoclax
Pharmacodynamic variables
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
APTIVATE Trial Design
4Treatment groups
Experimental Treatment
Group I: Part C Dose Expansion (tuspetinib as a single agent)Experimental Treatment1 Intervention
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.
Group II: Part C Dose Expansion (Combination Arm - tuspetinib and venetoclax)Experimental Treatment2 Interventions
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.
Group III: Part B Dose ExplorationExperimental Treatment1 Intervention
For Part B (tuspetinib as a single agent), dose exploration cohort is planned up to 4 dose levels.
Group IV: Part A Dose EscalationExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Hanmi Pharmaceutical Company LimitedLead Sponsor
185 Previous Clinical Trials
59,965 Total Patients Enrolled
Aptose Biosciences Inc.Lead Sponsor
7 Previous Clinical Trials
767 Total Patients Enrolled
Naval Daver, MDPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
197 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe and ongoing side effects from the transplant that are not related to blood problems.You have leukemia or another disease that has spread to your brain or central nervous system (CNS).You have a type of cancer other than acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that is currently active.You have a history of heart problems listed below:
- Heart attack
- Heart failure
- Abnormal heart rhythm
- Heart valve problems
- Blocked blood vessels in the heartYou have experienced severe side effects from a certain type of medication called tyrosine kinase inhibitor.You have severe side effects from previous treatments for AML that are still ongoing and affecting your body, with symptoms and test results to prove it.You have received a type of transplant called hematopoietic stem cell transplant (HSCT).You have a serious condition called graft-versus-host-disease (GVHD) that needs to be treated.You have already tried at least one cycle of treatment, but it did not work for you.You have had a relapse after getting better with a previous treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Part C Dose Expansion (Combination Arm - tuspetinib and venetoclax)
- Group 2: Part A Dose Escalation
- Group 3: Part B Dose Exploration
- Group 4: Part C Dose Expansion (tuspetinib as a single agent)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other kinds of trials are similar to this one?
"To date, there has only been one ongoing study for HM43239. This trial is being conducted across 3 cities in 2 different countries. The first ever clinical trial involving HM43239 was completed in 2019 by Aptose Biosciences Inc.. That particular study had 218 participants and successfully navigated Phase 1 & 2 of the drug approval process. In the years since 2019, an additional 34 trials have been carried out."
Answered by AI
Is this the first time that HM43239 has been used in research?
"The drug HM43239 was first trialled in 2019 at Asan Medical Center. To date, there have been a total of 34 completed studies. Out of these, 1 is an active clinical trial with the majority being conducted in Sacramento, California."
Answered by AI
Are we currently enrolling patients for this trial?
"The latest information on clinicaltrials.gov reveals that this trial is ongoing and recruiting patients. The listing was first created on March 11th, 2019 and updated September 13th, 2020."
Answered by AI
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