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

Sponsor
Aptose Biosciences Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03893682
Collaborator
(none)
160
Enrollment
31
Locations
1
Arm
48
Anticipated Duration (Months)
5.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
Anticipated 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 :
Apr 30, 2019
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

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 Names:
  • Luxeptinib

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of treatment-emergent adverse events of CG-806 [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 [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 [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) [Cycle 1 (28 days)]

      Pharmacokinetic variables including maximum plasma concentration (Cmax)

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

      Pharmacokinetic variables including Area Under the Curve (AUC)

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

      Pharmacokinetic variables including volume of distribution

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

      Pharmacokinetic variables including clearance

    6. Pharmacokinetic variables including serum half-life [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 [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 [Average 2 cycles (8 weeks)]

      Pharmacodynamic biomarkers of drug effect including BTK activity

    9. Pharmacodynamic biomarkers of drug effect including selected mRNA levels [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 [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 [Cycle 1 Lead-Up (3 days)]

      To assess the relative bioavailability of original formulation (G1) against new generation formulation (G3).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Phoenix Phoenix Arizona United States 85054
    2 University of California Los Angeles Los Angeles California United States 90095
    3 Pacific Cancer Care Monterey California United States 93940
    4 Torrance Memorial Physician Network Redondo Beach California United States 90277
    5 UCSD Moores Cancer Center San Diego California United States 92093
    6 Sharp Clinical Oncology Research San Diego California United States 92123
    7 Ridley-Tree Cancer Center Santa Barbara California United States 93105
    8 St. Joseph Heritage Heathcare Santa Rosa California United States 95403
    9 Rocky Mountain Cancer Centers Aurora Colorado United States 80012
    10 Mayo Clinic Jacksonville Jacksonville Florida United States 32224
    11 Orlando Health Orlando Florida United States 32806
    12 Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana United States 46804
    13 University of Maryland, Greenebaum Comprehensive Cancer Center Baltimore Maryland United States 21201
    14 The Center for Cancer and Blood Disorders a division of American Oncology Partners of Maryland, PA Bethesda Maryland United States 20817
    15 UMass Memorial Medical Center Worcester Massachusetts United States 01655
    16 University of Michigan Ann Arbor Michigan United States 48109
    17 Mayo Clinic Rochester Rochester Minnesota United States 55905
    18 SCL Health, St. Vincent Frontier Cancer Center Billings Montana United States 59102
    19 Morristown Medical Center Morristown New Jersey United States 07960
    20 Manhattan Hematology Oncology New York New York United States 10016
    21 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    22 Prisma Health - ITOR Greenville South Carolina United States 29605
    23 Carolina Blood and Cancer Care Associates Rock Hill South Carolina United States 29732
    24 Texas Oncology - Austin-Midtown Austin Texas United States 78705
    25 Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas United States 75246
    26 Texas Oncology - Fort Worth Cancer Center Fort Worth Texas United States 76104
    27 University of Texas, M.D. Anderson Cancer Center Houston Texas United States 77030
    28 University of Texas Health Science Center at San Antonio, Mays Cancer Center San Antonio Texas United States 78229
    29 Texas Oncology - Tyler Tyler Texas United States 75702
    30 Virginia Oncology Associates Norfolk Virginia United States 23502
    31 Northwest Cancer Specialists, P.C. - Compass Oncology Vancouver Washington United States 98684

    Sponsors and Collaborators

    • Aptose Biosciences Inc.

    Investigators

    • Study Director: Rafael Bejar, MD, PhD, Aptose Biosciences Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aptose Biosciences Inc.
    ClinicalTrials.gov Identifier:
    NCT03893682
    Other Study ID Numbers:
    • APTO-CG-806-01
    First Posted:
    Mar 28, 2019
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Lymphoma
    Lymphoma, Non-Hodgkin
    Leukemia, Lymphocytic, Chronic, B-Cell

    Study Results

    No Results Posted as of Mar 31, 2022