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

NCT03893682 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: APTO-CG-806-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 30

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.

Conditions

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

Keywords

Oral; DLBCL; PMBCL; BCLU; GZL; MCL; FL; MZL; WM; LPL; CLL; SLL

Outcome Measures

Primary Outcomes (3)

• Incidence of treatment-emergent adverse events of CG-806

  To determine the safety and tolerability of CG-806.

  Cycle 1 (28 days)

• 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)

• 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 Outcomes (11)

• Pharmacokinetic variables including maximum plasma concentration (Cmax)

  Cycle 1 (28 days)

• Pharmacokinetic variables including minimum plasma concentration (Cmin)

  Cycle 1 (28 days)

• 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 volume of distribution

  Cycle 1 (28 days)

• Pharmacokinetic variables including clearance

  Cycle 1 (28 days)

Study Arms (1)

Dose Escalation and Expansion

EXPERIMENTAL

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

Interventions

CG-806 DRUG

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.

Also known as: Luxeptinib

Dose Escalation and Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aptose Biosciences Inc.: lead

Study Sites (30)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Pacific Cancer Care

Monterey, California, 93940, United States

Location

Torrance Memorial Physician Network

Redondo Beach, California, 90277, United States

Location

UCSD Moores Cancer Center

San Diego, California, 92093, United States

Location

Sharp Clinical Oncology Research

San Diego, California, 92123, United States

Location

Ridley-Tree Cancer Center

Santa Barbara, California, 93105, United States

Location

St. Joseph Heritage Heathcare

Santa Rosa, California, 95403, United States

Location

Rocky Mountain Cancer Centers

Aurora, Colorado, 80012, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46804, United States

Location

University of Maryland, Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

Location

The Center for Cancer and Blood Disorders a division of American Oncology Partners of Maryland, PA

Bethesda, Maryland, 20817, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

SCL Health, St. Vincent Frontier Cancer Center

Billings, Montana, 59102, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Manhattan Hematology Oncology

New York, New York, 10016, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Prisma Health - ITOR

Greenville, South Carolina, 29605, United States

Location

Carolina Blood and Cancer Care Associates

Rock Hill, South Carolina, 29732, United States

Location

Texas Oncology - Austin-Midtown

Austin, Texas, 78705, United States

Location

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology - Fort Worth Cancer Center

Fort Worth, Texas, 76104, United States

Location

University of Texas, M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at San Antonio, Mays Cancer Center

San Antonio, Texas, 78229, United States

Location

Texas Oncology - Tyler

Tyler, Texas, 75702, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Northwest Cancer Specialists, P.C. - Compass Oncology

Vancouver, Washington, 98684, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma

Study Officials

• Rafael Bejar, MD, PhD

  Aptose Biosciences Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 28, 2019
• Study Start: April 30, 2019
• Primary Completion: May 17, 2024
• Study Completion: May 17, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (30)