This study is being done to evaluate the safety, tolerability and antitumor activity of oral
      CG-806 (luxeptinib) for the treatment of patients with Acute Myeloid Leukemia (except APML),
      secondary AML, therapy-related AML, or higher-risk MDS, whose disease has relapsed, is
      refractory or who are ineligible for or intolerant of intensive chemotherapy or
      transplantation.

A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS

Acute Myeloid Leukemia

Myelodysplastic Syndromes

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, therapy-related AML, or higher-risk MDS 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.

CG-806

A Phase 1a/b Trial of CG-806 in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndromes

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.

To determine the dose of CG-806 given orally every 12 hours daily that maintains a biologically active plasma concentration during 28-day cycles.

To establish the maximum tolerated dose and/or recommended Phase 2 dose (RP2D) of CG-806 for future clinical trials in patients with AML and other advanced myeloid malignancies.

Pharmacokinetics variables including maximum plasma concentration at various timepoints.

Pharmacokinetics variables including minimum plasma concentration at various timepoints.

Pharmacokinetics variables including plasma concentration at various timepoints.

To determine the ability of CG-806 to modulate the expression or activity of pharmacodynamic biomarkers of drug effect.

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.

Compare G1 to G3 pharmacokinetics variables including maximum plasma concentration (Cmax)

Compare G1 to G3 Pharmacokinetics variables including minimum plasma concentration (Cmin)

Compare G1 to G3 Pharmacokinetics variables including area under the curve (AUC)

Compare G1 to G3 Pharmacokinetics variables including volume of distribution

Compare G1 to G3 Pharmacokinetics variables including clearance

Compare G1 to G3 Pharmacokinetics variables including plasma half-life.

Dose Escalation and Expansion; CG-806 will be given orally in ascending doses in patients with relapsed or refractory AML or higher-risk MDS (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.

A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the Participation Requirements?

Locations

Location

Status