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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

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 more
Secondary outcome measures
Anti-leukemic activity of HM43239
Anti-leukemic activity of HM43239 in combination with venetoclax
Pharmacodynamic variables
+5 more

Awards & 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.

Find a Location

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

Tuspetinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03850574 — Phase 1 & 2
Acute Myeloid Leukemia Research Study Groups: Part C Dose Expansion (Combination Arm - tuspetinib and venetoclax), Part A Dose Escalation, Part B Dose Exploration, Part C Dose Expansion (tuspetinib as a single agent)
Acute Myeloid Leukemia Clinical Trial 2023: Tuspetinib Highlights & Side Effects. Trial Name: NCT03850574 — Phase 1 & 2
Tuspetinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03850574 — Phase 1 & 2

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
~8 spots leftby Feb 2024