Clinical trial NCT03893682: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Non-Hodgkin's Lymphoma
Keywords: Oral
DLBCL
PMBCL
BCLU
GZL
MCL
FL
MZL
WM
LPL
CLL
SLL
Lead sponsor: Aptose Biosciences Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events of CG-806
timeFrame: Cycle 1 (28 days)
measure: Establish a CG-806 dose that maintains a biologically active plasma concentration
timeFrame: Cycle 1 (28 days)
measure: Establish recommended dose for future development of CG-806
timeFrame: Up to 10 months
Secondary outcomes:
measure: Pharmacokinetic variables including maximum plasma concentration (Cmax)
timeFrame: Cycle 1 (28 days)
measure: Pharmacokinetic variables including minimum plasma concentration (Cmin)
timeFrame: Cycle 1 (28 days)
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
timeFrame: Cycle 1 (28 days)
measure: Pharmacokinetic variables including volume of distribution
timeFrame: Cycle 1 (28 days)
measure: Pharmacokinetic variables including clearance
timeFrame: Cycle 1 (28 days)
measure: Pharmacokinetic variables including serum half-life
timeFrame: Cycle 1 (28 days)
measure: To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations
timeFrame: Average 2 Cycles (8 weeks)
measure: Pharmacodynamic biomarkers of drug effect including BTK activity
timeFrame: Average 2 cycles (8 weeks)
measure: Pharmacodynamic biomarkers of drug effect including selected mRNA levels
timeFrame: Average 2 cycles (8 weeks)
measure: To assess the relative BA of formulation G1 against formulation G2
timeFrame: Cycle 1 (28 days)
measure: To assess the relative BA of formulation G1 against formulation G3
timeFrame: Cycle 1 Lead-Up (3 days)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Monterey
country: United States
facility: Pacific Cancer Care
state: California
city: Redondo Beach
country: United States
facility: Torrance Memorial Physician Network
state: California
city: San Diego
country: United States
facility: UCSD Moores Cancer Center
state: California
city: San Diego
country: United States
facility: Sharp Clinical Oncology Research
state: California
city: Santa Barbara
country: United States
facility: Ridley-Tree Cancer Center
state: California
city: Santa Rosa
country: United States
facility: St. Joseph Heritage Heathcare
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland, Greenebaum Comprehensive Cancer Center
state: Maryland
city: Bethesda
country: United States
facility: The Center for Cancer and Blood Disorders a division of American Oncology Partners of Maryland, PA
state: Maryland
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Billings
country: United States
facility: SCL Health, St. Vincent Frontier Cancer Center
state: Montana
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New York
country: United States
facility: Manhattan Hematology Oncology
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Greenville
country: United States
facility: Prisma Health - ITOR
state: South Carolina
city: Rock Hill
country: United States
facility: Carolina Blood and Cancer Care Associates
state: South Carolina
city: Austin
country: United States
facility: Texas Oncology - Austin-Midtown
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology - Fort Worth Cancer Center
state: Texas
city: Houston
country: United States
facility: University of Texas, M.D. Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio, Mays Cancer Center
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, P.C. - Compass Oncology
state: Washington
Study officials:
affiliation: Aptose Biosciences Inc.
name: Rafael Bejar, MD, PhD
role: STUDY_DIRECTOR
References: