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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

Must not have

Treatment with other investigational drugs or receipt of cytotoxic therapy within 14 days prior to first study treatment administration

Patients with GVHD requiring systemic immunosuppressive therapy

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken experimental drugs or had chemotherapy in the last 14 days.

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I have GVHD and need drugs to suppress my immune system.

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I have a dangerous increase in white blood cells.

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I do not have uncontrolled brain or spinal cord disease, autoimmune blood disorders, or significant metabolic issues.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Compare G1 to G3 Pharmacokinetics variables including clearance

Pharmacokinetics variables including area under the curve (AUC)

Pharmacokinetics variables including clearance

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met