A Study of CG-806 in Patients With Relapsed or Refractory CLL/SLL or Non-Hodgkin's Lymphomas
- Conditions
- Chronic Lymphocytic LeukemiaNon-Hodgkin's LymphomaSmall Lymphocytic Lymphoma
- Interventions
- Registration Number
- NCT03893682
- Lead Sponsor
- Aptose Biosciences Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 36
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation and Expansion CG-806 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.
- Primary Outcome Measures
Name Time Method 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.
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.
Incidence of treatment-emergent adverse events of CG-806 Cycle 1 (28 days) To determine the safety and tolerability of CG-806.
- Secondary Outcome Measures
Name Time Method Pharmacokinetic variables including maximum plasma concentration (Cmax) Cycle 1 (28 days) Pharmacokinetic variables including maximum plasma concentration (Cmax)
Pharmacokinetic variables including minimum plasma concentration (Cmin) Cycle 1 (28 days) 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 Cycle 1 (28 days) Pharmacokinetic variables including Area Under the Curve (AUC)
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).
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
Pharmacodynamic biomarkers of drug effect including selected mRNA levels Average 2 cycles (8 weeks) Pharmacodynamic biomarkers of drug effect including selected mRNA levels
Pharmacokinetic variables including serum half-life Cycle 1 (28 days) Pharmacokinetic variables including serum half-life
Pharmacokinetic variables including volume of distribution Cycle 1 (28 days) Pharmacokinetic variables including volume of distribution
Pharmacokinetic variables including clearance Cycle 1 (28 days) Pharmacokinetic variables including clearance
Pharmacodynamic biomarkers of drug effect including BTK activity Average 2 cycles (8 weeks) Pharmacodynamic biomarkers of drug effect including BTK activity
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).
Trial Locations
- Locations (30)
University of California Los Angeles
🇺🇸Los Angeles, California, United States
Fort Wayne Medical Oncology and Hematology
🇺🇸Fort Wayne, Indiana, United States
University of Maryland, Greenebaum Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Rocky Mountain Cancer Centers
🇺🇸Aurora, Colorado, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
UCSD Moores Cancer Center
🇺🇸San Diego, California, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Pacific Cancer Care
🇺🇸Monterey, California, United States
Torrance Memorial Physician Network
🇺🇸Redondo Beach, California, United States
Ridley-Tree Cancer Center
🇺🇸Santa Barbara, California, United States
St. Joseph Heritage Heathcare
🇺🇸Santa Rosa, California, United States
Sharp Clinical Oncology Research
🇺🇸San Diego, California, United States
The Center for Cancer and Blood Disorders a division of American Oncology Partners of Maryland, PA
🇺🇸Bethesda, Maryland, United States
Orlando Health
🇺🇸Orlando, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
SCL Health, St. Vincent Frontier Cancer Center
🇺🇸Billings, Montana, United States
Manhattan Hematology Oncology
🇺🇸New York, New York, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Carolina Blood and Cancer Care Associates
🇺🇸Rock Hill, South Carolina, United States
Prisma Health - ITOR
🇺🇸Greenville, South Carolina, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Texas Oncology - Austin-Midtown
🇺🇸Austin, Texas, United States
Texas Oncology - Fort Worth Cancer Center
🇺🇸Fort Worth, Texas, United States
University of Texas Health Science Center at San Antonio, Mays Cancer Center
🇺🇸San Antonio, Texas, United States
Texas Oncology - Tyler
🇺🇸Tyler, Texas, United States
University of Texas, M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
Northwest Cancer Specialists, P.C. - Compass Oncology
🇺🇸Vancouver, Washington, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States