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Trial record 3 of 8 for:    aptose
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A Study of CG-806 in Patients With Relapsed or Refractory CLL/SLL or Non-Hodgkin's Lymphomas

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: NCT03893682
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : January 5, 2023
Sponsor:
Information provided by (Responsible Party):
Aptose Biosciences Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Non-Hodgkin's Lymphoma Drug: CG-806 Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation and Expansion
CG-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.
 Drug: CG-806
CG-806 will be given orally in ascending doses starting at 150 mg PO BID until the maximum tolerated dose or recommended dose is reached.
Other Name: Luxeptinib


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events of CG-806 [ Time Frame: Cycle 1 (28 days) ]
    To determine the safety and tolerability of CG-806.

  2. Establish a CG-806 dose that maintains a biologically active plasma concentration [ Time Frame: Cycle 1 (28 days) ]
    To determine the dose of CG-806 given orally every 12 hours that maintains a biologically active plasma concentration over a period of 28 days.

  3. Establish recommended dose for future development of CG-806 [ Time Frame: Up to 10 months ]
    To establish the recommended Phase 2 dose (RP2D) of CG-806 for future clinical trials in patients with advanced CLL/SLL or NHL.


Secondary Outcome Measures :
  1. Pharmacokinetic variables including maximum plasma concentration (Cmax) [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including maximum plasma concentration (Cmax)

  2. Pharmacokinetic variables including minimum plasma concentration (Cmin) [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including minimum plasma concentration (Cmin)

  3. 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) ]
    Pharmacokinetic variables including Area Under the Curve (AUC)

  4. Pharmacokinetic variables including volume of distribution [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including volume of distribution

  5. Pharmacokinetic variables including clearance [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including clearance

  6. Pharmacokinetic variables including serum half-life [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including serum half-life

  7. To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations [ Time Frame: Average 2 Cycles (8 weeks) ]
    To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations

  8. Pharmacodynamic biomarkers of drug effect including BTK activity [ Time Frame: Average 2 cycles (8 weeks) ]
    Pharmacodynamic biomarkers of drug effect including BTK activity

  9. Pharmacodynamic biomarkers of drug effect including selected mRNA levels [ Time Frame: Average 2 cycles (8 weeks) ]
    Pharmacodynamic biomarkers of drug effect including selected mRNA levels

  10. To assess the relative BA of formulation G1 against formulation G2 [ Time Frame: Cycle 1 (28 days) ]
    To assess the relative bioavailability of original formulation (G1) against new generation formulation (G2).

  11. To assess the relative BA of formulation G1 against formulation G3 [ Time Frame: Cycle 1 Lead-Up (3 days) ]
    To assess the relative bioavailability of original formulation (G1) against new generation formulation (G3).


Eligibility Criteria
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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

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
Contacts and Locations
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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): NCT03893682


Contacts
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Contact: Nawazish Khan, MD 858-275-6359 NKhan@aptose.com
Contact: Rafael Bejar, MD,PhD 858-401-6852 RBejar@aptose.com

Locations
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Sponsors and Collaborators
Aptose Biosciences Inc.
Investigators
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Study Director: Rafael Bejar, MD, PhD Aptose Biosciences Inc.
More Information
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Responsible Party: Aptose Biosciences Inc.
ClinicalTrials.gov Identifier: NCT03893682    
Other Study ID Numbers: APTO-CG-806-01
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: January 5, 2023
Last Verified: January 2023
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.:
Oral
DLBCL
PMBCL
BCLU
GZL
MCL
 FL
MZL
WM
LPL
CLL
SLL
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Leukemia, Lymphoid
Leukemia
Leukemia, B-Cell
Chronic Disease
Disease Attributes
Pathologic Processes