<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04477291</url>
  </required_header>
  <id_info>
    <org_study_id>APTO-CG-806-03</org_study_id>
    <nct_id>NCT04477291</nct_id>
  </id_info>
  <brief_title>A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS</brief_title>
  <official_title>A Phase 1a/b Trial of CG-806 in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndromes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aptose Biosciences Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aptose Biosciences Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being done to evaluate the safety, tolerability and antitumor activity of oral&#xD;
      CG-806 (luxeptinib) for the treatment of patients with Acute Myeloid Leukemia (except APML),&#xD;
      secondary AML, therapy-related AML, or higher-risk MDS, whose disease has relapsed, is&#xD;
      refractory or who are ineligible for or intolerant of intensive chemotherapy or&#xD;
      transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, open-label, Phase 1 a/b dose escalation study of safety,&#xD;
      pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to&#xD;
      determine the MTD or recommended dose in patients with relapsed or refractory Acute Myeloid&#xD;
      Leukemia (except APML), secondary AML, therapy-related AML, or higher-risk MDS whose disease&#xD;
      has relapsed, is refractory or who are ineligible for or intolerant of intensive chemotherapy&#xD;
      or transplantation. This is to be followed by a cohort expansion phase.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 6, 2020</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of treatment-emergent adverse events of CG-806</measure>
    <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Establish a CG-806 dose that maintains a biologically active plasma concentration</measure>
    <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
    <description>To determine the dose of CG-806 given orally every 12 hours daily that maintains a biologically active plasma concentration during 28-day cycles.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Establish a recommended dose for future development of CG-806</measure>
    <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics variables including maximum plasma concentration (Cmax).</measure>
    <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
    <description>Pharmacokinetics variables including maximum plasma concentration at various timepoints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics variables including minimum plasma concentration (Cmin)</measure>
    <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
    <description>Pharmacokinetics variables including minimum plasma concentration at various timepoints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics variables including area under the curve (AUC)</measure>
    <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
    <description>Pharmacokinetics variables including plasma concentration at various timepoints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics variables including volume of distribution</measure>
    <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
    <description>Pharmacokinetics variables including plasma concentration at various timepoints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics variables including clearance</measure>
    <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
    <description>Pharmacokinetics variables including plasma concentration at various timepoints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics variables including plasma half-life.</measure>
    <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
    <description>Pharmacokinetics variables including plasma concentration at various timepoints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the ability of CG-806 to modulate the expression or activity of pharmacodynamic biomarkers of drug effect.</measure>
    <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
    <description>To determine the ability of CG-806 to modulate the expression or activity of pharmacodynamic biomarkers of drug effect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess patients for evidence of anti-tumor activity of CG-806 based on hematologic, bone marrow, physical examination, evaluations</measure>
    <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the Relative Bioavailability of Generation 3 formulation given to up to 18 patients on Cycle 1 Day -3 compared to Generation 1 formulation of study drug given to patients during Cycle 1.</measure>
    <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
    <description>Compare G1 to G3 pharmacokinetics variables including maximum plasma concentration (Cmax)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the Relative Bioavailability of Generation 3 formulation given to up to 18 patients on Cycle 1 Day -3 compared to Generation 1 formulation of study drug given to patients during Cycle 1.</measure>
    <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
    <description>Compare G1 to G3 Pharmacokinetics variables including minimum plasma concentration (Cmin)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the Relative Bioavailability of Generation 3 formulation given to up to 18 patients on Cycle 1 Day -3 compared to Generation 1 formulation of study drug given to patients during Cycle 1.</measure>
    <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
    <description>Compare G1 to G3 Pharmacokinetics variables including area under the curve (AUC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the Relative Bioavailability of Generation 3 formulation given to up to 18</measure>
    <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
    <description>Compare G1 to G3 Pharmacokinetics variables including volume of distribution</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the Relative Bioavailability of Generation 3 formulation given to up to 18</measure>
    <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
    <description>Compare G1 to G3 Pharmacokinetics variables including clearance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare G1 to G3 Pharmacokinetics variables including clearance</measure>
    <time_frame>At the end of Cycle 1 (each cycle is 28 days)</time_frame>
    <description>Compare G1 to G3 Pharmacokinetics variables including plasma half-life.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <condition>Myelodysplastic Syndromes</condition>
  <arm_group>
    <arm_group_label>Dose Escalation and Expansion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose Escalation and Expansion; CG-806 will be given orally in ascending doses in patients with relapsed or refractory AML or higher-risk MDS (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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CG-806</intervention_name>
    <description>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.</description>
    <arm_group_label>Dose Escalation and Expansion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Life expectancy of at least 3 months&#xD;
&#xD;
          -  ECOG Performance Status ≤ 2&#xD;
&#xD;
          -  Patients must be able to swallow capsules&#xD;
&#xD;
          -  Adequate hematologic parameters, unless cytopenias are disease caused&#xD;
&#xD;
          -  Adequate renal, liver and cardiac functions&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Patients with GVHD requiring systemic immunosuppressive therapy&#xD;
&#xD;
          -  Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and&#xD;
             clinically significant disease related metabolic disorder&#xD;
&#xD;
          -  Clinically significant leukostasis&#xD;
&#xD;
          -  Treatment with other investigational drugs or receipt of cytotoxic therapy within 14&#xD;
             days prior to first study treatment administration&#xD;
&#xD;
          -  Receipt of cellular immunotherapeutic agents within 4 weeks prior to first study&#xD;
             treatment administration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rafael Bejar, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Aptose Biosciences Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nawazish Khan, MD, MS</last_name>
    <phone>858-275-6359</phone>
    <email>nkhan@aptose.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rafael Bejar, MD, PhD</last_name>
    <phone>858-401-6852</phone>
    <email>rbejar@aptose.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>City of Hope National Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rochelle Hernandez</last_name>
      <phone>626-218-0247</phone>
      <email>rochernandez@coh.org</email>
    </contact>
    <investigator>
      <last_name>Paul Koller, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St Joseph Heritage Healthcare</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christine Duran</last_name>
      <email>duran_c@med.usc.edu</email>
    </contact>
    <investigator>
      <last_name>Eric L Tam, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Posada</last_name>
      <email>jxp2320@med.miami.edu</email>
    </contact>
    <investigator>
      <last_name>Namrata Chandhok, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sophia Rollyson</last_name>
      <phone>312-695-8128</phone>
      <email>sophia.rollyson@northwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Jessica Altman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ochsner Healthcare</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natalie Santos</last_name>
      <phone>504-703-2652</phone>
      <email>Natalie.santos@ochsner.org</email>
    </contact>
    <contact_backup>
      <last_name>Michelle Schmidt</last_name>
      <phone>504-842-6097</phone>
      <email>michelle.schmidt@ochsner.org</email>
    </contact_backup>
    <investigator>
      <last_name>Laura Finn, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Atlantic Hematological Oncology Center</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07962</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Salome Geene</last_name>
      <phone>973-971-6373</phone>
      <email>salome.geene@atlantichealth.org</email>
    </contact>
    <contact_backup>
      <last_name>Amanda Hall</last_name>
      <phone>973-971-5235</phone>
      <email>AmandaMaria.Hall@atlantichealth.org</email>
    </contact_backup>
    <investigator>
      <last_name>Mohamad Cherry, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Roswell Park Comprehensive Cancer Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Naa-Akomaah Yeboah</last_name>
      <email>yeboahn1@mskcc.org</email>
    </contact>
    <contact_backup>
      <last_name>Michelle Gianvito</last_name>
      <email>gianvitm@mskcc.org</email>
    </contact_backup>
    <investigator>
      <last_name>Aaron Goldberg, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital of Cleveland</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarah Golwitzer</last_name>
      <phone>216-286-0112</phone>
      <email>Sarah.Gollwitzer@UHhospitals.org</email>
    </contact>
    <contact_backup>
      <last_name>Susan Ackerman</last_name>
      <phone>216-286-4150</phone>
      <email>susan.ackerman2@uhhospitals.org</email>
    </contact_backup>
    <investigator>
      <last_name>Benjamin Tomlinson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julio Guerrero</last_name>
      <phone>713-745-6771</phone>
      <email>jaguerrero@mdanderson.org</email>
    </contact>
    <investigator>
      <last_name>Maro Ohanian, DO</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>June 20, 2023</last_update_submitted>
  <last_update_submitted_qc>June 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CG-806</keyword>
  <keyword>Aptose</keyword>
  <keyword>FLT3</keyword>
  <keyword>FLT3-ITD</keyword>
  <keyword>D835Y</keyword>
  <keyword>F691L</keyword>
  <keyword>BTK</keyword>
  <keyword>C481S</keyword>
  <keyword>TP53</keyword>
  <keyword>NRAS</keyword>
  <keyword>IDH1</keyword>
  <keyword>BCL2</keyword>
  <keyword>Gilteritinib</keyword>
  <keyword>Quizartinib</keyword>
  <keyword>Midostaurin</keyword>
  <keyword>Crenolanib</keyword>
  <keyword>Venetoclax</keyword>
  <keyword>Ibrutinib</keyword>
  <keyword>Acalabrutinib</keyword>
  <keyword>Zanubrutinib</keyword>
  <keyword>LOXO-305</keyword>
  <keyword>ARQ 531</keyword>
  <keyword>AML</keyword>
  <keyword>Acute Myeloid Leukemia</keyword>
  <keyword>MDS</keyword>
  <keyword>Myelodysplastic Syndrome</keyword>
  <keyword>CLL</keyword>
  <keyword>Chronic Lymphocytic Leukemia</keyword>
  <keyword>Resistant</keyword>
  <keyword>Refractory</keyword>
  <keyword>Relapsed</keyword>
  <keyword>Intolerant</keyword>
  <keyword>Kinase Inhibitor</keyword>
  <keyword>Non covalent</keyword>
  <keyword>Luxeptinib</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04477291
org study id: APTO-CG-806-03
nct id: NCT04477291
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is being done to evaluate the safety, tolerability and antitumor activity of oral
      CG-806 (luxeptinib) for the treatment of patients with Acute Myeloid Leukemia (except APML),
      secondary AML, therapy-related AML, or higher-risk MDS, whose disease has relapsed, is
      refractory or who are ineligible for or intolerant of intensive chemotherapy or
      transplantation.
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, therapy-related AML, or higher-risk MDS 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.
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of treatment-emergent adverse events of CG-806
time frame: At the end of Cycle 1 (each cycle is 28 days)
description: 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.
measure: 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)
description: To determine the dose of CG-806 given orally every 12 hours daily that maintains a biologically active plasma concentration during 28-day cycles.
measure: Establish a recommended dose for future development of CG-806
time frame: At the end of Cycle 1 (each cycle is 28 days)
description: 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.
measure: Pharmacokinetics variables including maximum plasma concentration (Cmax).
time frame: At the end of Cycle 1 (each cycle is 28 days)
description: Pharmacokinetics variables including maximum plasma concentration at various timepoints.
measure: Pharmacokinetics variables including minimum plasma concentration (Cmin)
time frame: At the end of Cycle 1 (each cycle is 28 days)
description: Pharmacokinetics variables including minimum plasma concentration at various timepoints.
measure: Pharmacokinetics variables including area under the curve (AUC)
time frame: At the end of Cycle 1 (each cycle is 28 days)
description: Pharmacokinetics variables including plasma concentration at various timepoints.
measure: Pharmacokinetics variables including volume of distribution
time frame: At the end of Cycle 1 (each cycle is 28 days)
description: Pharmacokinetics variables including plasma concentration at various timepoints.
measure: Pharmacokinetics variables including clearance
time frame: At the end of Cycle 1 (each cycle is 28 days)
description: Pharmacokinetics variables including plasma concentration at various timepoints.
measure: Pharmacokinetics variables including plasma half-life.
time frame: At the end of Cycle 1 (each cycle is 28 days)
description: Pharmacokinetics variables including plasma concentration at various timepoints.
measure: 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)
description: To determine the ability of CG-806 to modulate the expression or activity of pharmacodynamic biomarkers of drug effect.
measure: To assess patients for evidence of anti-tumor activity of CG-806 based on hematologic, bone marrow, physical examination, evaluations
time frame: At the end of Cycle 1 (each cycle is 28 days)
description: 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.
measure: To determine the Relative Bioavailability of Generation 3 formulation given to up to 18 patients on Cycle 1 Day -3 compared to Generation 1 formulation of study drug given to patients during Cycle 1.
time frame: At the end of Cycle 1 (each cycle is 28 days)
description: Compare G1 to G3 pharmacokinetics variables including maximum plasma concentration (Cmax)
measure: To determine the Relative Bioavailability of Generation 3 formulation given to up to 18 patients on Cycle 1 Day -3 compared to Generation 1 formulation of study drug given to patients during Cycle 1.
time frame: At the end of Cycle 1 (each cycle is 28 days)
description: Compare G1 to G3 Pharmacokinetics variables including minimum plasma concentration (Cmin)
measure: To determine the Relative Bioavailability of Generation 3 formulation given to up to 18 patients on Cycle 1 Day -3 compared to Generation 1 formulation of study drug given to patients during Cycle 1.
time frame: At the end of Cycle 1 (each cycle is 28 days)
description: Compare G1 to G3 Pharmacokinetics variables including area under the curve (AUC)
measure: To determine the Relative Bioavailability of Generation 3 formulation given to up to 18
time frame: At the end of Cycle 1 (each cycle is 28 days)
description: Compare G1 to G3 Pharmacokinetics variables including volume of distribution
measure: To determine the Relative Bioavailability of Generation 3 formulation given to up to 18
time frame: At the end of Cycle 1 (each cycle is 28 days)
description: Compare G1 to G3 Pharmacokinetics variables including clearance
measure: Compare G1 to G3 Pharmacokinetics variables including clearance
time frame: At the end of Cycle 1 (each cycle is 28 days)
description: Compare G1 to G3 Pharmacokinetics variables including plasma half-life.
arm group label: Dose Escalation and Expansion
arm group type: Experimental
description: Dose Escalation and Expansion; CG-806 will be given orally in ascending doses in patients with relapsed or refractory AML or higher-risk MDS (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 type: Drug
intervention name: CG-806
description: 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.
arm group label: Dose Escalation and Expansion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rafael Bejar, MD, PhD
role: Study Director
affiliation: Aptose Biosciences Inc.
last name: Nawazish Khan, MD, MS
phone: 858-275-6359
email: nkhan@aptose.com
last name: Rafael Bejar, MD, PhD
phone: 858-401-6852
email: rbejar@aptose.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Preleukemia
mesh term: Myelodysplastic Syndromes
mesh term: Syndrome
sharing ipd: No