Clinical Trials /

A Study of CG-806 in Patients With Relapsed or Refractory CLL/SLL or Non-Hodgkin's Lymphomas

NCT03893682

Description:

This study is being done to evaluate the safety, tolerability and effectiveness of Oral CG-806 for the treatment of patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or Non-Hodgkin's Lymphomas who have failed or are intolerant to two or more lines of established therapy or for whom no other treatment options are available.

Related Conditions:
  • Chronic Lymphocytic Leukemia
  • Non-Hodgkin Lymphoma
  • Small Lymphocytic Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of CG-806 in Patients With Relapsed or Refractory CLL/SLL or Non-Hodgkin's Lymphomas
  • Official Title: A Phase Ia/b Trial to Evaluate the Safety and Tolerability of CG-806 in Patients With CLL/SLL or Non-Hodgkin's Lymphomas

Clinical Trial IDs

  • ORG STUDY ID: APTO-CG-806-01
  • NCT ID: NCT03893682

Conditions

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Non-Hodgkin's Lymphoma

Interventions

DrugSynonymsArms
CG-806Dose Escalation and Expansion

Purpose

This study is being done to evaluate the safety, tolerability and effectiveness of Oral CG-806 for the treatment of patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or Non-Hodgkin's Lymphomas who have failed or are intolerant to two or more lines of established therapy or for whom no other treatment options are available.

Detailed Description

      This is a multicenter, open-label, Phase Ia/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 CLL/SLL or
      Non-Hodgkin's Lymphoma patients. This is to be followed by a cohort expansion phase at the
      MTD or recommended oral dose.
    

Trial Arms

NameTypeDescriptionInterventions
Dose Escalation and ExpansionExperimentalCG-806 will be given orally in ascending doses in patients with relapsed or refractory CLL/SLL or Non-Hodgkin's Lymphomas (escalation cohort), until the maximum tolerated dose or recommended dose is reached. Followed by up to 100 patients enrolled in the expansion cohort at the recommended dose.
  • CG-806

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Life expectancy of at least 2 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 function 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of treatment-emergent adverse events of CG-806
Time Frame:Cycle 1 (28 days)
Safety Issue:
Description:To determine the safety and tolerability of CG-806.

Secondary Outcome Measures

Measure:Pharmacokinetic variables including maximum plasma concentration (Cmax)
Time Frame:Cycle 1 (28 days)
Safety Issue:
Description:Pharmacokinetic variables including maximum plasma concentration (Cmax)
Measure:Pharmacokinetic variables including minimum plasma concentration (Cmin)
Time Frame:Cycle 1 (28 days)
Safety Issue:
Description:Pharmacokinetic variables including minimum plasma concentration (Cmin)
Measure:Pharmacokinetic variables including Area Under the Curve (AUC) Pharmacokinetic variables including Area Under the Curve (AUC Pharmacokinetic variables including Area Under the Curve (AUC
Time Frame:Cycle 1 (28 days)
Safety Issue:
Description:Pharmacokinetic variables including Area Under the Curve (AUC)
Measure:Pharmacokinetic variables including volume of distribution
Time Frame:Cycle 1 (28 days)
Safety Issue:
Description:Pharmacokinetic variables including volume of distribution
Measure:Pharmacokinetic variables including clearance
Time Frame:Cycle 1 (28 days)
Safety Issue:
Description:Pharmacokinetic variables including clearance
Measure:Pharmacokinetic variables including serum half-life
Time Frame:Cycle 1 (28 days)
Safety Issue:
Description:Pharmacokinetic variables including serum half-life
Measure:To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations
Time Frame:Average 2 Cycles (8 weeks)
Safety Issue:
Description:To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations
Measure:Pharmacodynamic biomarkers of drug effect including BTK activity
Time Frame:Average 2 cycles (8 weeks)
Safety Issue:
Description:Pharmacodynamic biomarkers of drug effect including BTK activity
Measure:Pharmacodynamic biomarkers of drug effect including selected mRNA levels
Time Frame:Average 2 cycles (8 weeks)
Safety Issue:
Description:Pharmacodynamic biomarkers of drug effect including selected mRNA levels

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Aptose Biosciences Inc.

Trial Keywords

  • Oral
  • DLBCL
  • PMBCL
  • BCLU
  • GZL
  • MCL
  • FL
  • MZL
  • WM
  • LPL
  • CLL
  • SLL

Last Updated

January 9, 2020