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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.

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: CG-806 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a/b Trial of CG-806 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Actual Study Start Date : October 6, 2020
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : June 2023


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. Pharmacokinetics variables including clearance [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    Pharmacokinetics variables including clearance

  6. 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

  7. 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.

  8. 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.



Information from the National Library of Medicine

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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

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

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): NCT04477291


Contacts
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Contact: Rafael Bejar, MD, PhD 858-401-6852 rbejar@aptose.com

Locations
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United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Lucia Magos    626-218-5801      
St Joseph Heritage Healthcare Recruiting
Fullerton, California, United States, 92835
Contact: Teresa Olea    714-446-5900      
United States, New Jersey
Atlantic Hematological Oncology Center Recruiting
Morristown, New Jersey, United States, 07962
Contact: Leah Zitelli    973-971-7960      
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Madhulika Shukla    646-888-0992      
United States, Ohio
University Hospital of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Sarah Houser    216-286-7082      
Sponsors and Collaborators
Aptose Biosciences Inc.
Investigators
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Study Director: Rafael Bejar, MD, PhD Aptose Biosciences Inc.
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Responsible Party: Aptose Biosciences Inc.
ClinicalTrials.gov Identifier: NCT04477291    
Other Study ID Numbers: APTO-CG-806-03
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aptose Biosciences Inc.:
CG-806
Aptose
FLT3
FLT3-ITD
D835Y
F691L
BTK
C481S
TP53
NRAS
IDH1
BCL2
Gilteritinib
Quizartinib
Midostaurin
Crenolanib
Venetoclax
Ibrutinib
Acalabrutinib
Zanubrutinib
LOXO-305
ARQ 531
AML
Acute Myeloid Leukemia
MDS
Myelodysplastic Syndrome
CLL
Chronic Lymphocytic Leukemia
Resistant
Refractory
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms