Description:
This study is being done to evaluate the safety, tolerability and antitumor activity of oral
CG-806 for the treatment of patients with Acute Myeloid Leukemia (except APML), secondary
AML, or therapy-related AML whose disease has relapsed, is refractory or who are ineligible
for or intolerant of intensive chemotherapy or transplantation.
Title
- Brief Title: A Study of CG-806 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
- Official Title: A Phase 1a/b Trial of CG-806 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Clinical Trial IDs
- ORG STUDY ID:
APTO-CG-806-03
- NCT ID:
NCT04477291
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| CG-806 | | Dose Escalation and Expansion |
Purpose
This study is being done to evaluate the safety, tolerability and antitumor activity of oral
CG-806 for the treatment of patients with Acute Myeloid Leukemia (except APML), secondary
AML, or therapy-related AML whose disease has relapsed, is refractory or who are ineligible
for or intolerant of intensive chemotherapy or transplantation.
Detailed Description
This is a multicenter, open-label, Phase 1 a/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 Acute Myeloid
Leukemia (except APML), secondary AML, or therapy-related AML whose disease has relapsed, is
refractory or who are ineligible for or intolerant of intensive chemotherapy or
transplantation. This is to be followed by a cohort expansion phase.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Dose Escalation and Expansion | Experimental | Dose Escalation and Expansion; CG-806 will be given orally in ascending doses in patients with relapsed or refractory AML (escalation cohort), until the maximum tolerated dose or candidate recommended Phase 2 dose is reached. Followed up by up to 50 patients enrolled in the expansion cohort at the recommended dose. | |
Eligibility Criteria
Key Inclusion Criteria:
- Age ≥18 years
- Life expectancy of at least 3 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 functions
Key Exclusion Criteria:
- Patients with GVHD requiring systemic immunosuppressive therapy
- Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and
clinically significant disease related metabolic disorder
- Clinically significant leukostasis
- 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: | At the end of Cycle 1 (each cycle is 28 days) |
| Safety Issue: | |
| Description: | Patients will be assessed for adverse events during all cycles of treatment and for dose limiting toxicities in Cycle 1 (28-days). Dose escalation to a higher dose level will be considered if none of the first three patients who complete Cycle 1 (28-days) at a given dose level experience a dose limiting toxicity or if only 1 of 6 patients at a given dose level experience a dose-limiting toxicity. |
Secondary Outcome Measures
| Measure: | Pharmacokinetics variables including maximum plasma concentration (Cmax) |
| Time Frame: | At the end of Cycle 1 (each cycle is 28 days) |
| Safety Issue: | |
| Description: | Pharmacokinetics variables including maximum plasma concentration (Cmax) |
| Measure: | Pharmacokinetics variables including minimum plasma concentration (Cmin) |
| Time Frame: | At the end of Cycle 1 (each cycle is 28 days) |
| Safety Issue: | |
| Description: | Pharmacokinetics variables including minimum plasma concentration (Cmin) |
| Measure: | Pharmacokinetics variables including area under the curve (AUC) |
| Time Frame: | At the end of Cycle 1 (each cycle is 28 days) |
| Safety Issue: | |
| Description: | Pharmacokinetics variables including area under the curve (AUC) |
| Measure: | Pharmacokinetics variables including volume of distribution |
| Time Frame: | At the end of Cycle 1 (each cycle is 28 days) |
| Safety Issue: | |
| Description: | Pharmacokinetics variables including volume of distribution |
| Measure: | Pharmacokinetics variables including clearance |
| Time Frame: | At the end of Cycle 1 (each cycle is 28 days) |
| Safety Issue: | |
| Description: | Pharmacokinetics variables including clearance |
| Measure: | Pharmacokinetics variables including serum half-life |
| Time Frame: | At the end of Cycle 1 (each cycle is 28 days) |
| Safety Issue: | |
| Description: | Pharmacokinetics variables including serum half-life |
| Measure: | To assess patients for evidence of anti-tumor activity of CG-806 based on hematologic, bone marrow, physical examination, and FDG PET-CT imaging evaluations |
| Time Frame: | At the end of Cycle 1 (each cycle is 28 days) |
| Safety Issue: | |
| Description: | To assess patients for evidence of anti-tumor activity of CG-806 based on hematologic, bone marrow, physical examination, and FDG PET-CT imaging evaluations. |
| Measure: | To determine the ability of CG-806 to modulate the expression or activity of pharmacodynamic biomarkers of drug effect. |
| Time Frame: | At the end of Cycle 1 (each cycle is 28 days) |
| Safety Issue: | |
| Description: | To determine the ability of CG-806 to modulate the expression or activity of pharmacodynamic biomarkers of drug effect. |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Aptose Biosciences Inc. |
Trial Keywords
- CG-806
- Aptose
- FLT3
- FLT3-ITD
- D835Y
- F691L
- BTK
- C481S
- TP53
- NRAS
- IDH1
- BCL2
- Gilteritinib
- Quizartinib
- Midostaurin
- Crenolanib
- Venetoclax
- Ibrutinib
- Acalabrutinib
- Zanubrutinib
- LOXO-305
- ARQ 531
- AML
- Acute Myeloid Leukemia
- MDS
- Myelodysplastic Syndrome
- CLL
- Chronic Lymphocytic Leukemia
- Resistant
- Refractory
- Relapsed
- Intolerant
- Kinase Inhibitor
- Non covalent
- Luxeptinib
Last Updated
July 21, 2021
