Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion
Principal Investigator
Erin Reid, MD
Photo of Erin Reid
Erin Reid

Description

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.

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

Details

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.

Keywords

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Non-Hodgkin's Lymphoma Oral DLBCL PMBCL BCLU GZL MCL FL MZL WM LPL CLL SLL Lymphoma Lymphoma, Non-Hodgkin Leukemia, Lymphocytic, Chronic, B-Cell Dose Escalation and Expansion

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Locations

  • UCSD Moores Cancer Center accepting new patients
    San Diego California 92093 United States
  • Sharp Clinical Oncology Research accepting new patients
    San Diego California 92123 United States

Lead Scientist at UCSD

  • Erin Reid, MD
    Dr. Reid’s broad research interests are to develop and conduct clinical trials for hematologic malignancies. She has made significant progress in the developing a concentration on AIDS-related lymphoma and Kaposi’s sarcoma. Fellow - Hematology-Oncology, Stanford University - 2001-2003 Fellow - Hematology-Oncology, University of California, San Diego - 2004

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aptose Biosciences Inc.
ID
NCT03893682
Phase
Phase 1
Study Type
Interventional
Last Updated