Study Stopped
Drug manufacturing process and procedure review
A Study of APTO-253 in Patients With Relapsed or Refractory AML or MDS
A Phase Ia/b Dose Escalation and Expansion, Multicenter, Open-label, Safety, Pharmacokinetic and Pharmacodynamic Study of APTO-253 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia or High-Risk Myelodysplasia
1 other identifier
interventional
21
1 country
13
Brief Summary
This study is being done to evaluate the safety and effectiveness of APTO-253 for the treatment of patients with the condition of acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) for which either the standard treatment has failed, is no longer effective, or can no longer be administered safely or poses a risk for your general well being.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2014
Longer than P75 for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 3, 2014
CompletedFirst Posted
Study publicly available on registry
October 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedAugust 22, 2022
August 1, 2022
6.9 years
October 3, 2014
August 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of treatment-emergent adverse events of APTO-253
To determine the safety and tolerability of APTO-253 by assessing treatment-related adverse events as assessed by CTCAE v4.0.
Cycle 1 (28 days)
Maximum tolerated dose and dose limiting toxicities
To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of APTO-253 when given on days 1, 8, 15, and 22 of each 28-day cycle.
Cycle 1 (28 days)
Establish recommended dose for future development of APTO-253
To establish the dose of APTO-253 recommended for future development of APTO-253 for patients with specific types of hematologic malignancies.
Up to 7 months
Secondary Outcomes (8)
Pharmacokinetic variables including maximum plasma concentration (Cmax)
Cycle 1 (28 days)
Pharmacokinetic variables including minimum plasma concentration (Cmin)
Cycle 1 (28 days)
Pharmacokinetic variables including Area Under the Curve (AUC)
Cycle 1 (28 days)
Pharmacokinetic variables including volume of distribution
Cycle 1 (28 days)
Pharmacokinetic variables including clearance
Cycle 1 (28 days)
- +3 more secondary outcomes
Study Arms (1)
Dose Escalation and Expansion
EXPERIMENTALAPTO-253 will be given in ascending doses in patients with relapsed or refractory AML or high risk MDS (escalation cohort), until the maximum tolerated dose or recommended dose is reached. Followed by up to 30 patients enrolled in the expansion cohort at the recommended dose.
Interventions
APTO-253 will be given in ascending doses starting at 20 mg/m2 until the maximum tolerated dose or recommended dose is reached.
Eligibility Criteria
You may qualify if:
- Patients ≥18 years old
- Life expectancy of at least 2 months
- Off previous cancer therapy for at least 14 days, or 5 half-lives for noncytotoxic agents prior to first study treatment administration
- Patients must have a calculated creatinine clearance \>60 mL/min
- Acceptable hematologic, renal and liver functions and coagulation status parameters
You may not qualify if:
- Patients with GVHD requiring systemic immunosuppressive therapy
- Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinical significant disease related metabolic disorder
- Clinically significant intravascular coagulation
- Treatment with other investigational drugs within 14 days prior to first study treatment administration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093-0698, United States
University of California, Irvine
Orange, California, 92868, United States
Emory University; Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Ochsner Cancer Institute
New Orleans, Louisiana, 70121, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
St. Vincent Frontier Cancer Center
Billings, Montana, 59102, United States
University of Rochester; Wilmot Cancer Institute Clinical Trials Office
Rochester, New York, 14643, United States
University Hospital
Cleveland, Ohio, 44106, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Prisma Health, Institute for Translational Oncology Research
Greenville, South Carolina, 29605, United States
Baylor Research Institute
Dallas, Texas, 75246, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rafael Bejar, MD., PhD.
Aptose Biosciences Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2014
First Posted
October 20, 2014
Study Start
October 1, 2014
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
August 22, 2022
Record last verified: 2022-08