Description:
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.
Title
- Brief Title: A Study of CG-806 in Patients With Relapsed or Refractory CLL/SLL or Non-Hodgkin's Lymphomas
- 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 IDs
- ORG STUDY ID:
APTO-CG-806-01
- NCT ID:
NCT03893682
Conditions
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
- Non-Hodgkin's Lymphoma
Interventions
| Drug | Synonyms | Arms |
|---|
| CG-806 | Luxeptinib | Dose Escalation and Expansion |
Purpose
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.
Detailed 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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| 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. | |
Eligibility Criteria
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Incidence of treatment-emergent adverse events of CG-806 |
| Time Frame: | Cycle 1 (28 days) |
| Safety Issue: | |
| Description: | To determine the safety and tolerability of CG-806. |
Secondary Outcome Measures
| Measure: | Pharmacokinetic variables including maximum plasma concentration (Cmax) |
| Time Frame: | Cycle 1 (28 days) |
| Safety Issue: | |
| Description: | Pharmacokinetic variables including maximum plasma concentration (Cmax) |
| Measure: | Pharmacokinetic variables including minimum plasma concentration (Cmin) |
| Time Frame: | Cycle 1 (28 days) |
| Safety Issue: | |
| Description: | Pharmacokinetic variables including minimum plasma concentration (Cmin) |
| Measure: | 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) |
| Safety Issue: | |
| Description: | Pharmacokinetic variables including Area Under the Curve (AUC) |
| Measure: | Pharmacokinetic variables including volume of distribution |
| Time Frame: | Cycle 1 (28 days) |
| Safety Issue: | |
| Description: | Pharmacokinetic variables including volume of distribution |
| Measure: | Pharmacokinetic variables including clearance |
| Time Frame: | Cycle 1 (28 days) |
| Safety Issue: | |
| Description: | Pharmacokinetic variables including clearance |
| Measure: | Pharmacokinetic variables including serum half-life |
| Time Frame: | Cycle 1 (28 days) |
| Safety Issue: | |
| Description: | Pharmacokinetic variables including serum half-life |
| Measure: | To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations |
| Time Frame: | Average 2 Cycles (8 weeks) |
| Safety Issue: | |
| Description: | To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations |
| Measure: | Pharmacodynamic biomarkers of drug effect including BTK activity |
| Time Frame: | Average 2 cycles (8 weeks) |
| Safety Issue: | |
| Description: | Pharmacodynamic biomarkers of drug effect including BTK activity |
| Measure: | Pharmacodynamic biomarkers of drug effect including selected mRNA levels |
| Time Frame: | Average 2 cycles (8 weeks) |
| Safety Issue: | |
| Description: | Pharmacodynamic biomarkers of drug effect including selected mRNA levels |
| Measure: | To assess the relative BA of formulation G1 against formulation G2 |
| Time Frame: | Cycle 1 (28 days) |
| Safety Issue: | |
| Description: | To assess the relative bioavailability of original formulation (G1) against new generation formulation (G2). |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Aptose Biosciences Inc. |
Trial Keywords
- Oral
- DLBCL
- PMBCL
- BCLU
- GZL
- MCL
- FL
- MZL
- WM
- LPL
- CLL
- SLL
Last Updated
August 30, 2021
