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

Primary Purpose

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

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CG-806
Sponsored by
Aptose Biosciences Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Oral, DLBCL, PMBCL, BCLU, GZL, MCL, FL, MZL, WM, LPL, CLL, SLL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California Los Angeles
  • Pacific Cancer Care
  • Torrance Memorial Physician Network
  • UCSD Moores Cancer Center
  • Sharp Clinical Oncology Research
  • Ridley-Tree Cancer Center
  • St. Joseph Heritage Heathcare
  • Rocky Mountain Cancer Centers
  • Mayo Clinic Jacksonville
  • Orlando Health
  • Fort Wayne Medical Oncology and Hematology
  • University of Maryland, Greenebaum Comprehensive Cancer Center
  • The Center for Cancer and Blood Disorders a division of American Oncology Partners of Maryland, PA
  • UMass Memorial Medical Center
  • University of Michigan
  • Mayo Clinic Rochester
  • SCL Health, St. Vincent Frontier Cancer Center
  • Morristown Medical Center
  • Manhattan Hematology Oncology
  • Memorial Sloan Kettering Cancer Center
  • Prisma Health - ITOR
  • Carolina Blood and Cancer Care Associates
  • Texas Oncology - Austin-Midtown
  • Texas Oncology - Baylor Charles A. Sammons Cancer Center
  • Texas Oncology - Fort Worth Cancer Center
  • University of Texas, M.D. Anderson Cancer Center
  • University of Texas Health Science Center at San Antonio, Mays Cancer Center
  • Texas Oncology - Tyler
  • Virginia Oncology Associates
  • Northwest Cancer Specialists, P.C. - Compass Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose Escalation and Expansion

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events of CG-806
To determine the safety and tolerability of CG-806.
Establish a CG-806 dose that maintains a biologically active plasma concentration
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.
Establish recommended dose for future development of CG-806
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

Pharmacokinetic variables including maximum plasma concentration (Cmax)
Pharmacokinetic variables including maximum plasma concentration (Cmax)
Pharmacokinetic variables including minimum plasma concentration (Cmin)
Pharmacokinetic variables including minimum plasma concentration (Cmin)
Pharmacokinetic variables including Area Under the Curve (AUC) Pharmacokinetic variables including Area Under the Curve (AUC Pharmacokinetic variables including Area Under the Curve (AUC
Pharmacokinetic variables including Area Under the Curve (AUC)
Pharmacokinetic variables including volume of distribution
Pharmacokinetic variables including volume of distribution
Pharmacokinetic variables including clearance
Pharmacokinetic variables including clearance
Pharmacokinetic variables including serum half-life
Pharmacokinetic variables including serum half-life
To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations
To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations
Pharmacodynamic biomarkers of drug effect including BTK activity
Pharmacodynamic biomarkers of drug effect including BTK activity
Pharmacodynamic biomarkers of drug effect including selected mRNA levels
Pharmacodynamic biomarkers of drug effect including selected mRNA levels
To assess the relative BA of formulation G1 against formulation G2
To assess the relative bioavailability of original formulation (G1) against new generation formulation (G2).
To assess the relative BA of formulation G1 against formulation G3
To assess the relative bioavailability of original formulation (G1) against new generation formulation (G3).

Full Information

First Posted
March 25, 2019
Last Updated
June 20, 2023
Sponsor
Aptose Biosciences Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03893682
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aptose Biosciences Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Non-Hodgkin's Lymphoma
Keywords
Oral, DLBCL, PMBCL, BCLU, GZL, MCL, FL, MZL, WM, LPL, CLL, SLL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation and Expansion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CG-806
Other Intervention Name(s)
Luxeptinib
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events of CG-806
Description
To determine the safety and tolerability of CG-806.
Time Frame
Cycle 1 (28 days)
Title
Establish a CG-806 dose that maintains a biologically active plasma concentration
Description
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.
Time Frame
Cycle 1 (28 days)
Title
Establish recommended dose for future development of CG-806
Description
To establish the recommended Phase 2 dose (RP2D) of CG-806 for future clinical trials in patients with advanced CLL/SLL or NHL.
Time Frame
Up to 10 months
Secondary Outcome Measure Information:
Title
Pharmacokinetic variables including maximum plasma concentration (Cmax)
Description
Pharmacokinetic variables including maximum plasma concentration (Cmax)
Time Frame
Cycle 1 (28 days)
Title
Pharmacokinetic variables including minimum plasma concentration (Cmin)
Description
Pharmacokinetic variables including minimum plasma concentration (Cmin)
Time Frame
Cycle 1 (28 days)
Title
Pharmacokinetic variables including Area Under the Curve (AUC) Pharmacokinetic variables including Area Under the Curve (AUC Pharmacokinetic variables including Area Under the Curve (AUC
Description
Pharmacokinetic variables including Area Under the Curve (AUC)
Time Frame
Cycle 1 (28 days)
Title
Pharmacokinetic variables including volume of distribution
Description
Pharmacokinetic variables including volume of distribution
Time Frame
Cycle 1 (28 days)
Title
Pharmacokinetic variables including clearance
Description
Pharmacokinetic variables including clearance
Time Frame
Cycle 1 (28 days)
Title
Pharmacokinetic variables including serum half-life
Description
Pharmacokinetic variables including serum half-life
Time Frame
Cycle 1 (28 days)
Title
To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations
Description
To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations
Time Frame
Average 2 Cycles (8 weeks)
Title
Pharmacodynamic biomarkers of drug effect including BTK activity
Description
Pharmacodynamic biomarkers of drug effect including BTK activity
Time Frame
Average 2 cycles (8 weeks)
Title
Pharmacodynamic biomarkers of drug effect including selected mRNA levels
Description
Pharmacodynamic biomarkers of drug effect including selected mRNA levels
Time Frame
Average 2 cycles (8 weeks)
Title
To assess the relative BA of formulation G1 against formulation G2
Description
To assess the relative bioavailability of original formulation (G1) against new generation formulation (G2).
Time Frame
Cycle 1 (28 days)
Title
To assess the relative BA of formulation G1 against formulation G3
Description
To assess the relative bioavailability of original formulation (G1) against new generation formulation (G3).
Time Frame
Cycle 1 Lead-Up (3 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Bejar, MD, PhD
Organizational Affiliation
Aptose Biosciences Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pacific Cancer Care
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
Torrance Memorial Physician Network
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
UCSD Moores Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Sharp Clinical Oncology Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Ridley-Tree Cancer Center
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
St. Joseph Heritage Heathcare
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
University of Maryland, Greenebaum Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
The Center for Cancer and Blood Disorders a division of American Oncology Partners of Maryland, PA
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
SCL Health, St. Vincent Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Manhattan Hematology Oncology
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Prisma Health - ITOR
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Carolina Blood and Cancer Care Associates
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Texas Oncology - Austin-Midtown
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Oncology - Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology - Fort Worth Cancer Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of Texas, M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio, Mays Cancer Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Northwest Cancer Specialists, P.C. - Compass Oncology
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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