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A Study of APTO-253 in Patients With Relapsed or Refractory AML or MDS

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ClinicalTrials.gov Identifier: NCT02267863
Recruitment Status : Recruiting
First Posted : October 20, 2014
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Aptose Biosciences Inc.

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.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia in Relapse Acute Myelogenous Leukemia, Relapsed, Adult Acute Myelogenous Leukemia, Adult Acute Myelogenous Leukemia High Risk Myelodysplasia Drug: APTO-253 Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2014
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Pharmacokinetic variables including maximum plasma concentration (Cmax) [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including maximum plasma concentration (Cmax)

  2. Pharmacokinetic variables including minimum plasma concentration (Cmin) [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including minimum plasma concentration (Cmin)

  3. Pharmacokinetic variables including Area Under the Curve (AUC) [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including Area Under the Curve (AUC)

  4. Pharmacokinetic variables including volume of distribution [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including volume of distribution

  5. Pharmacokinetic variables including clearance [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including clearance

  6. Pharmacokinetic variables including serum half-life [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including serum half-life

  7. 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.

  8. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267863


Contacts
Contact: Monica Wynn 858-926-2737 mwynn@aptose.com
Contact: Nicole Harada 858-926-2730 nharada@aptose.com

Locations
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Moshe Talpaz, MD         
United States, Texas
Baylor Research Institute Recruiting
Dallas, Texas, United States, 75246
Contact: Erica Goetz, RN, BSN    214-818-8325    erica.goetz@baylorhealth.edu   
Principal Investigator: Moshe Y. Levy, MD         
MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Principal Investigator: Maro Ohanian, DO         
Sponsors and Collaborators
Aptose Biosciences Inc.
Investigators
Study Director: Stephen Howell, MD Aptose Biosciences Inc.

Additional Information:
Responsible Party: Aptose Biosciences Inc.
ClinicalTrials.gov Identifier: NCT02267863     History of Changes
Other Study ID Numbers: 253-HEM1-01
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018

Keywords provided by Aptose Biosciences Inc.:
AML
MDS
Leukemia
Acute Myeloid Leukemia
Aptose
APTO-253
Kinase Inhibitor

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions