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

NCT04477291 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-03-07

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

CG-806

CG-806 will be given orally in ascending doses starting at 450 mg PO BID until the maximum tolerated dose or candidate recommended Phase 2 dose is reached.

Sponsors & Collaborators

  • Aptose Biosciences Inc.

    lead INDUSTRY

Principal Investigators

  • Rafael Bejar, MD, PhD · Aptose Biosciences Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-06
Primary Completion
2024-04-15
Completion
2024-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04477291 on ClinicalTrials.gov