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Trial record 1 of 6 for:    Aptose
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A Study of APTO-253 in Patients With Relapsed or Refractory AML or MDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02267863
Recruitment Status : Recruiting
First Posted : October 20, 2014
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Aptose Biosciences Inc.

Tracking Information
First Submitted Date  ICMJE October 3, 2014
First Posted Date  ICMJE October 20, 2014
Last Update Posted Date June 4, 2020
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
  • Incidence of treatment-emergent adverse events of APTO-253 [ Time Frame: Cycle 1 (28 days) ]
    To determine the safety and tolerability of APTO-253 by assessing treatment-related adverse events as assessed by CTCAE v4.0.
  • Maximum tolerated dose and dose limiting toxicities [ Time Frame: Cycle 1 (28 days) ]
    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.
  • Establish recommended dose for future development of APTO-253 [ Time Frame: Up to 7 months ]
    To establish the dose of APTO-253 recommended for future development of APTO-253 for patients with specific types of hematologic malignancies.
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2014)
Maximum tolerated dose and dose limiting toxicities [ Time Frame: 4 weeks ]
To determine the maximum tolerated dose and the dose limiting toxicities of APTO-253 HCl with twice weekly dosing in a 28-day cycle to establish the dose recommended for future phase 2 studies for patients with hematologic malignancies.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
  • Pharmacokinetic variables including maximum plasma concentration (Cmax) [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including maximum plasma concentration (Cmax)
  • Pharmacokinetic variables including minimum plasma concentration (Cmin) [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including minimum plasma concentration (Cmin)
  • Pharmacokinetic variables including Area Under the Curve (AUC) [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including Area Under the Curve (AUC)
  • Pharmacokinetic variables including volume of distribution [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including volume of distribution
  • Pharmacokinetic variables including clearance [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including clearance
  • Pharmacokinetic variables including serum half-life [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including serum half-life
  • Assess for any evidence of antitumor activity of APTO-253 by hematologic and bone marrow evaluations in acute leukemia and MDS. [ Time Frame: Average 2 Cycles (8 weeks) ]
    To observe patients for any evidence of antitumor activity of APTO-253 by hematologic and bone marrow evaluations in acute leukemia and MDS.
  • Determine the ability of APTO-253 to alter the expression of pharmacodynamic biomarkers of drug effect. [ Time Frame: Average 2 Cycles (8 weeks) ]
    To determine the ability of APTO-253 to alter the expression of pharmacodynamic biomarkers of drug effect.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2014)
  • Pharmacokinetic variables including Cmax, Css, AUC and Kel [ Time Frame: Cycle 1 (28 days) ]
  • Change from baseline of KLF4, CDX2 and p21 pharmacodynamic variables [ Time Frame: Average 2 Cycles (8 weeks) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of APTO-253 in Patients With Relapsed or Refractory AML or MDS
Official Title  ICMJE A Phase Ib 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
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.
Detailed Description This is a multicenter, open-label, Phase Ib dose escalation study of safety, pharmacodynamics, and pharmacokinetics of APTO-253 in ascending cohorts (3+3 design) to determine the MTD or recommended dose in patients with relapsed or refractory acute myelogenous leukemia (AML) or high-risk MDS patients. This is to be followed by a cohort expansion phase at the MTD or recommended dose.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Myelogenous Leukemia in Relapse
  • Acute Myelogenous Leukemia, Relapsed, Adult
  • Acute Myelogenous Leukemia, Adult
  • Acute Myelogenous Leukemia
  • High Risk Myelodysplasia
Intervention  ICMJE Drug: APTO-253
APTO-253 will be given in ascending doses starting at 20 mg/m2 until the maximum tolerated dose or recommended dose is reached.
Study Arms  ICMJE Experimental: Dose Escalation and Expansion
APTO-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.
Intervention: Drug: APTO-253
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 16, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ashleigh Campillo 858-333-6118 acampillo@aptose.com
Contact: Victor Montalvo Lugo 858-926-2740 VMontalvo@aptose.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02267863
Other Study ID Numbers  ICMJE 253-HEM1-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aptose Biosciences Inc.
Study Sponsor  ICMJE Aptose Biosciences Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rafael Bejar, MD., PhD. Aptose Biosciences Inc.
PRS Account Aptose Biosciences Inc.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP