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

Phase 1TerminatedNCT03893682

Aptose Biosciences Inc.36 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

CG-806DRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (30)

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events of CG-806

To determine the safety and tolerability of CG-806.

Time frame: 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.

Time frame: 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.

Time frame: Up to 10 months

Secondary Outcomes

Pharmacokinetic variables including maximum plasma concentration (Cmax)

Time frame: Cycle 1 (28 days)

Pharmacokinetic variables including minimum plasma concentration (Cmin)

Time frame: 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

Pharmacokinetic variables including Area Under the Curve (AUC)

Time frame: Cycle 1 (28 days)

Pharmacokinetic variables including volume of distribution

Data from ClinicalTrials.gov

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