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NCT03850574 · ClinicalTrials.gov registry record · Phase 1
Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study of Chronic Myelomonocytic Leukemia and Leukemia, Myeloid, Acute, sponsored by Aptose Biosciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 240
- Enrollment target
- 20
- Study locations
NCT03850574 is a Phase 1 study of Chronic Myelomonocytic Leukemia and Leukemia, Myeloid, Acute that is actively recruiting participants, run by Aptose Biosciences. The registered enrollment target is 240 participants, above the 85-participant average among 73 other Chronic Myelomonocytic Leukemia trials with a reported enrollment target (182% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT03850574, a Phase 1 study of Chronic Myelomonocytic Leukemia and Leukemia, Myeloid, Acute, is actively recruiting participants, sponsored by Aptose Biosciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 240 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Tuspetinib
- DRUG Venetoclax Oral Tablet
- DRUG Azacitidine for Intravenous Infusion
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center - Duarte
- University of California Irvine - Irvine
- UCSD Moores Cancer Center - La Jolla
- USC/Norris Comprehensive Cancer Center - Los Angeles
- Stanford Cancer Center - Palo Alto
- University of California, Davis - Sacramento
Ohio
- Cleveland Clinic - Taussig Cancer Center - Cleveland
- The Ohio State University Wexner Medical Center - Columbus
Queensland
- Royal Brisbane and Women's Hospital - Herston
- Townsville University Hospital - Townsville
Alabama
- The Kirklin Clinic of UAB Hospital - Birmingham
Connecticut
- Yale University - New Haven
Florida
- University of Miami - Miller School of Medicine - Miami
Georgia
- Emory University - Atlanta
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2019-03-11 |
| Est. Completion | 2027-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03850574
The ClinicalTrials.gov registry entry for NCT03850574 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 85-participant average among 73 other Chronic Myelomonocytic Leukemia trials with a reported enrollment target (182% higher). The listed sponsor is Aptose Biosciences, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Chronic Myelomonocytic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Tuspetinib is the first listed.
NCT03850574 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Ohio, Queensland.
Frequently Asked Questions
What is clinical trial NCT03850574 about?
NCT03850574 is a clinical study titled "Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia". 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 (CMM...
What is the current status of trial NCT03850574?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 240 participants. The study started on 2019-03-11. Estimated completion is 2027-04.
What conditions does trial NCT03850574 study?
This clinical trial studies the following conditions: Chronic Myelomonocytic Leukemia, Leukemia, Myeloid, Acute, Myelodysplastic Syndrome With Excess Blasts-2, Refractory AML, Relapsed Adult AML.
What interventions are being tested in trial NCT03850574?
The interventions under investigation include: Tuspetinib (DRUG), Venetoclax Oral Tablet (DRUG), Azacitidine for Intravenous Infusion (DRUG).
Who is sponsoring clinical trial NCT03850574?
This trial is sponsored by Aptose Biosciences, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03850574 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.