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

Chronic Lymphocytic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03893682
• Other study ID #: APTO-CG-806-01
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 30, 2019
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Aptose Biosciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma
• Small Lymphocytic Lymphoma

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Rocky Mountain Cancer Centers	Aurora	Colorado
United States	Texas Oncology - Austin-Midtown	Austin	Texas
United States	University of Maryland, Greenebaum Comprehensive Cancer Center	Baltimore	Maryland
United States	The Center for Cancer and Blood Disorders a division of American Oncology Partners of Maryland, PA	Bethesda	Maryland
United States	SCL Health, St. Vincent Frontier Cancer Center	Billings	Montana
United States	Texas Oncology - Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana
United States	Texas Oncology - Fort Worth Cancer Center	Fort Worth	Texas
United States	Prisma Health - ITOR	Greenville	South Carolina
United States	University of Texas, M.D. Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	University of California Los Angeles	Los Angeles	California
United States	Pacific Cancer Care	Monterey	California
United States	Morristown Medical Center	Morristown	New Jersey
United States	Manhattan Hematology Oncology	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Orlando Health	Orlando	Florida
United States	Torrance Memorial Physician Network	Redondo Beach	California
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Carolina Blood and Cancer Care Associates	Rock Hill	South Carolina
United States	University of Texas Health Science Center at San Antonio, Mays Cancer Center	San Antonio	Texas
United States	Sharp Clinical Oncology Research	San Diego	California
United States	UCSD Moores Cancer Center	San Diego	California
United States	Ridley-Tree Cancer Center	Santa Barbara	California
United States	St. Joseph Heritage Heathcare	Santa Rosa	California
United States	Texas Oncology - Tyler	Tyler	Texas
United States	Northwest Cancer Specialists, P.C. - Compass Oncology	Vancouver	Washington
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Aptose Biosciences Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events of CG-806	To determine the safety and tolerability of CG-806.	Cycle 1 (28 days)
Primary	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.	Cycle 1 (28 days)
Primary	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.	Up to 10 months
Secondary	Pharmacokinetic variables including maximum plasma concentration (Cmax)	Pharmacokinetic variables including maximum plasma concentration (Cmax)	Cycle 1 (28 days)
Secondary	Pharmacokinetic variables including minimum plasma concentration (Cmin)	Pharmacokinetic variables including minimum plasma concentration (Cmin)	Cycle 1 (28 days)
Secondary	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)	Cycle 1 (28 days)
Secondary	Pharmacokinetic variables including volume of distribution	Pharmacokinetic variables including volume of distribution	Cycle 1 (28 days)
Secondary	Pharmacokinetic variables including clearance	Pharmacokinetic variables including clearance	Cycle 1 (28 days)
Secondary	Pharmacokinetic variables including serum half-life	Pharmacokinetic variables including serum half-life	Cycle 1 (28 days)
Secondary	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	Average 2 Cycles (8 weeks)
Secondary	Pharmacodynamic biomarkers of drug effect including BTK activity	Pharmacodynamic biomarkers of drug effect including BTK activity	Average 2 cycles (8 weeks)
Secondary	Pharmacodynamic biomarkers of drug effect including selected mRNA levels	Pharmacodynamic biomarkers of drug effect including selected mRNA levels	Average 2 cycles (8 weeks)
Secondary	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).	Cycle 1 (28 days)
Secondary	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).	Cycle 1 Lead-Up (3 days)