CG-806 for CLL & NHL

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Trial Summary

Recruiting

A Phase Ia/b Trial to Evaluate the Safety and Tolerability of CG-806 in Patients With CLL/SLL or Non-Hodgkin's Lymphomas

Condition

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

Actual Start Date

April 30, 2019

Estimated Primary Completion Date

November 2020

About the Trial

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

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 dose.

Detailed Info

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.

Study Phase

Phase 1

Estimated Enrollment

130

Estimated Primary Completion Date

November 2020

Study Type

Interventional

Interventions

  • Drug: CG-806

Sponsor

Aptose Biosciences Inc.

Eligibility

Inclusion Criteria

Gender

All

Age

18 years and older

Eastern Cooperative Oncology Group performance status

0-2

  • 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

The Eastern Cooperative Oncology Group (ECOG) performance status allows patients to be classified as to their functional impairment. Scores run from 0 to 5; the higher the ECOG score, the worse the survival rate for most serious cancers. This score allows physicians to evaluate a patient's ability to survive chemotherapy for cancer.

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

Locations

The following cities have CG-806 clinical trial sites. Please check back often as locations will be updated.

Enrollment

For more information on enrollment in our current clinical trials, please contact us or visit clinicaltrials.gov for location information.

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The safety and efficacy of the investigational use of these products have not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.