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Tyrosine Kinase Inhibitor

CG-806 for Acute Myeloid Leukemia and High-Risk MDS

Phase 1

Waitlist Available

Research Sponsored by Aptose Biosciences Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

ECOG Performance Status ≤ 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of cycle 1 (each cycle is 28 days)

Awards & highlights

Study Summary

This trial is testing a new drug, CG-806, to see if it is safe and effective in treating patients with leukemia or MDS who have relapsed or are unresponsive to other treatments.

Who is the study for?

This trial is for adults over 18 with relapsed or stubborn Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS), who can't have intense chemo or a transplant. They should be fairly active, able to swallow pills, and not on other experimental drugs recently.Check my eligibility

What is being tested?

The study tests CG-806 (luxeptinib), an oral medication, to see if it's safe and effective against certain types of AML/MDS that haven't responded well to other treatments or when patients can't handle stronger therapies.See study design

What are the potential side effects?

While the specific side effects of CG-806 are not listed here, common ones in cancer trials may include nausea, fatigue, liver issues, blood count changes leading to increased infection risk or bleeding problems. Each person's experience could vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of cycle 1 (each cycle is 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of cycle 1 (each cycle is 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of cycle 1 (each cycle is 28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Establish a CG-806 dose that maintains a biologically active plasma concentration

Establish a recommended dose for future development of CG-806

Incidence of treatment-emergent adverse events of CG-806

Secondary outcome measures

Compare G1 to G3 Pharmacokinetics variables including clearance

Pharmacokinetics variables including area under the curve (AUC)

Pharmacokinetics variables including clearance

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation and ExpansionExperimental Treatment1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Aptose Biosciences Inc.Lead Sponsor

7 Previous Clinical Trials

905 Total Patients Enrolled

Rafael Bejar, MD, PhDStudy DirectorAptose Biosciences Inc.

1 Previous Clinical Trials

160 Total Patients Enrolled

Media Library

CG-806 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04477291 — Phase 1

Acute Myeloid Leukemia Research Study Groups: Dose Escalation and Expansion

Acute Myeloid Leukemia Clinical Trial 2023: CG-806 Highlights & Side Effects. Trial Name: NCT04477291 — Phase 1

CG-806 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04477291 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity of participants for this research endeavor?

"Aptose Biosciences Inc. needs 80 participants who fulfill the study's prerequisites to successfully complete it. These trials will be conducted at Ochsner Healthcare in Louisiana and Memorial Sloan Kettering Cancer Center in New york City."

Answered by AI

What is the principal purpose of this clinical experiment?

"This 28-day trial seeks to ascertain the optimal dosage of CG-806. Further, secondary objectives include measuring pharmacokinetic metrics such as Cmax (maximum plasma concentration), serum half-life, and Cmin (minimum plasma concentration) at designated time points."

Answered by AI

Has the FDA approved CG-806 for medical usage?

"CG-806's safety was given a rating of 1 due to the limited information available in its Phase 1 clinical trial, where data on efficacy and security is still being collected."

Answered by AI

In what geographical areas are the operations of this trial concentrated?

"Ochsner Healthcare in New Orleans, Memorial Sloan Kettering Cancer Center in NYC, and City of Hope National Medical Center in Duarte are only a few of the medical centres that will be recruiting patients for this trial. There are 9 additional sites where potential participants can apply."

Answered by AI

Is the enrollment process currently open for this investigation?

"As per data on clinicaltrials.gov, this medical trial is still open for recruitment. It was first posted on October 6th 2020 and the latest edit to the page occurred on March 4th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04477291.

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