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A Study of CG-806 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

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: NCT04477291
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Aptose Biosciences Inc.

Tracking Information
First Submitted Date  ICMJE July 13, 2020
First Posted Date  ICMJE July 20, 2020
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE October 6, 2020
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2020)
  • Incidence of treatment-emergent adverse events of CG-806 [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    Patients will be assessed for adverse events during all cycles of treatment and for dose limiting toxicities in Cycle 1 (28-days). Dose escalation to a higher dose level will be considered if none of the first three patients who complete Cycle 1 (28-days) at a given dose level experience a dose limiting toxicity or if only 1 of 6 patients at a given dose level experience a dose-limiting toxicity.
  • Establish a CG-806 dose that maintains a biologically active plasma concentration [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    To determine the dose of CG-806 given orally every 12 hours daily that maintains a biologically active plasma concentration during 28-day cycles.
  • Establish a recommended dose for future development of CG-806 [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    To establish the maximum tolerated dose and/or recommended Phase 2 dose (RP2D) of CG-806 for future clinical trials in patients with AML and other advanced myeloid malignancies.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2020)
  • Pharmacokinetics variables including maximum plasma concentration (Cmax) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    Pharmacokinetics variables including maximum plasma concentration (Cmax)
  • Pharmacokinetics variables including minimum plasma concentration (Cmin) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    Pharmacokinetics variables including minimum plasma concentration (Cmin)
  • Pharmacokinetics variables including area under the curve (AUC) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    Pharmacokinetics variables including area under the curve (AUC)
  • Pharmacokinetics variables including volume of distribution [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    Pharmacokinetics variables including volume of distribution
  • Pharmacokinetics variables including clearance [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    Pharmacokinetics variables including clearance
  • Pharmacokinetics variables including serum half-life [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    Pharmacokinetics variables including serum half-life
  • To assess patients for evidence of anti-tumor activity of CG-806 based on hematologic, bone marrow, physical examination, and FDG PET-CT imaging evaluations [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    To assess patients for evidence of anti-tumor activity of CG-806 based on hematologic, bone marrow, physical examination, and FDG PET-CT imaging evaluations.
  • To determine the ability of CG-806 to modulate the expression or activity of pharmacodynamic biomarkers of drug effect. [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    To determine the ability of CG-806 to modulate the expression or activity of pharmacodynamic biomarkers of drug effect.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of CG-806 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Official Title  ICMJE A Phase 1a/b Trial of CG-806 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Brief Summary This study is being done to evaluate the safety, tolerability and antitumor activity of oral CG-806 for the treatment of patients with Acute Myeloid Leukemia (except APML), secondary AML, or therapy-related AML whose disease has relapsed, is refractory or who are ineligible for or intolerant of intensive chemotherapy or transplantation.
Detailed Description This is a multicenter, open-label, Phase 1 a/b dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the MTD or recommended dose in patients with relapsed or refractory Acute Myeloid Leukemia (except APML), secondary AML, or therapy-related AML whose disease has relapsed, is refractory or who are ineligible for or intolerant of intensive chemotherapy or transplantation. This is to be followed by a cohort expansion phase at the candidate recommended Phase 2 dose.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE Drug: CG-806
CG-806 will be given orally in ascending doses starting at 450 mg PO BID until the maximum tolerated dose or candidate recommended Phase 2 dose is reached.
Study Arms  ICMJE Experimental: Dose Escalation and Expansion
Dose Escalation and Expansion; CG-806 will be given orally in ascending doses in patients with relapsed or refractory AML (escalation cohort), until the maximum tolerated dose or candidate recommended Phase 2 dose is reached. Followed up by up to 50 patients enrolled in the expansion cohort at the recommended dose.
Intervention: Drug: CG-806
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: July 15, 2020)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Age ≥18 years
  • Life expectancy of at least 3 months
  • ECOG Performance Status ≤ 2
  • Patients must be able to swallow capsules
  • Adequate hematologic parameters, unless cytopenias are disease caused
  • Adequate renal, liver and cardiac functions

Key Exclusion Criteria:

  • Patients with GVHD requiring systemic immunosuppressive therapy
  • Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinically significant disease related metabolic disorder
  • Clinically significant leukostasis
  • 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: Rafael Bejar, MD, PhD 858-401-6852 rbejar@aptose.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04477291
Other Study ID Numbers  ICMJE APTO-CG-806-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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 October 2020

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