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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Aptose Biosciences Inc.
Study ID
NCT03850574
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Myelomonocytic Leukemia
  • Leukemia, Myeloid, Acute
  • Myelodysplastic Syndrome With Excess Blasts-2
  • Refractory AML
  • Relapsed Adult AML

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tuspetinib — DRUG
    Daily (QD), continuous dosing
  • Venetoclax Oral Tablet — DRUG
    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
  • Azacitidine for Intravenous Infusion — DRUG
    Azacitidine will be given to study participants in Part D as intravenous infusion at a dose of 75 mg/m\^2

Study Details

The main purpose of this study is to identify a safe and potentially effective dose of tuspetinib to be used in future studies in study participants diagnosed with acute myeloid leukemia (AML), myelodysplastic syndromes with increased blasts grade 2 (MDS-IB2), or chronic myelomonocytic leukemia (CMML) that is relapsed or refractory after at least one line of prior therapy, or in study participants with newly diagnosed AML. Tuspetinib will be administered as a single agent or in combination with other drugs (venetoclax or venetoclax plus azacitidine), as specified for each part of the study.

Key Dates

Start date
Mar 11, 2019
Status verified
Aug 2025
Primary completion
Nov 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
240 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A Dose Escalation [COMPLETED]
    Part A dose escalation of tuspetinib as a single agent is planned for up to 6 dose levels. If a study participant in dose escalation 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 participants (\<1/6 DLT observed) in Part A, up to 20 evaluable participants can be enrolled in Part B at that dose level.
  • Experimental: Part B Dose Exploration [ACTIVE, NOT RECRUITING]
    Part B dose exploration of tuspetinib as a single agent is planned for up to 4 dose levels.
  • Experimental: Part C Dose Expansion (tuspetinib as a single agent) [COMPLETE]
    Part C dose expansion of tuspetinib as a single agent is planned for 2 dose levels. Study participants will be randomly assigned to either arm based on the number of slots available. The initial tuspetinib dose will be 120 mg.
  • Experimental: Part C Dose Expansion (tuspetinib plus venetoclax) [COMPLETE]
    Part C dose expansion of tuspetinib in combination with venetoclax is planned for 2 dose levels. The initial tuspetinib dose will be 80 mg.
  • Experimental: Part D Dose Exploration (tuspetinib plus venetoclax and azacitidine) [ACTIVE, RECRUITING - US Sites]
    Part D dose exploration of tuspetinib in combination with venetoclax and azacitidine is planned for up to 6 dose levels. The initial tuspetinib dose will be 40 mg.

Primary Outcome Measure

Frequency and severity of drug-related adverse events [ Time Frame: 4 years ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
The Kirklin Clinic of UAB HospitalBirminghamAlabama35233
Pankit Vachhani, MD
[email protected]
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
University of California IrvineIrvineCalifornia92697
Deepa Jeyakumar, MD
[email protected]
Deepa Jeyakumar, MD (PRINCIPAL_INVESTIGATOR)
UCSD Moores Cancer CenterLa JollaCalifornia92093-
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Eric Tam, MD
[email protected]
Eric Tam, MD (PRINCIPAL_INVESTIGATOR)
Stanford Cancer CenterPalo AltoCalifornia94304
Gabriel Mannis, MD
[email protected]
Gabriel Mannis, MD (PRINCIPAL_INVESTIGATOR)
University of California, DavisSacramentoCalifornia95817
Brian Jonas
[email protected]
(916) 703-9151
Yale UniversityNew HavenConnecticut06520
Nikolai Podoltsev, MD
[email protected]
Nikolai Podoltsev, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Miami - Miller School of MedicineMiamiFlorida33136
Justin Watts, MD
[email protected]
Emory UniversityAtlantaGeorgia30322-
Massachusetts General HospitalBostonMassachusetts02114-
Duke University Medical CenterDurhamNorth Carolina27705
Harry Erba, MD
[email protected]
Cleveland Clinic - Taussig Cancer CenterClevelandOhio44106-
The Ohio State University Wexner Medical CenterColumbusOhio43210
Uma Borate, MD
[email protected]
Uma Borate, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHustonTexas77030
Naval Daver, Dr
[email protected]
713-792-6477

Find similar trials in Birmingham, AL

By research site
The Kirklin Clinic of UAB Hospital· Birmingham, ALCity of Hope Comprehensive Cancer Center· Duarte, CAUniversity of California Irvine· Irvine, CAUCSD Moores Cancer Center· La Jolla, CAUSC/Norris Comprehensive Cancer Center· Los Angeles, CAStanford Cancer Center· Palo Alto, CA

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