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History of Changes for Study: NCT04477291
A Study of CG-806 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Latest version (submitted March 4, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 15, 2020 None (earliest Version on record)
2 October 19, 2020 Recruitment Status, Study Status, Contacts/Locations, Study Design and Oversight
3 July 15, 2021 Contacts/Locations, Study Status, Study Design, Conditions and Study Description
4 March 4, 2022 Outcome Measures, Contacts/Locations, Study Description, Study Status, Study Identification, Eligibility, Arms and Interventions and Conditions
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Study NCT04477291
Submitted Date:  July 15, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: APTO-CG-806-03
Brief Title: A Study of CG-806 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Official Title: A Phase 1a/b Trial of CG-806 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2020
Overall Status: Not yet recruiting
Study Start: July 2020
Primary Completion: November 2022 [Anticipated]
Study Completion: June 2023 [Anticipated]
First Submitted: July 13, 2020
First Submitted that
Met QC Criteria:
July 15, 2020
First Posted: July 20, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
July 15, 2020
Last Update Posted: July 20, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Aptose Biosciences Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Acute Myeloid Leukemia
Keywords: 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
Relapsed
Intolerant
Kinase Inhibitor
Non covalent
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Sequential Assignment
Number of Arms: 1
Masking: None (Open Label)
Enrollment: 80 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Rafael Bejar, MD, PhD
Telephone: 858-401-6852
Email: rbejar@aptose.com
Study Officials: Rafael Bejar, MD, PhD
Study Director
Aptose Biosciences Inc.
Locations: United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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