CG-806 for Acute Myeloid Leukemia

Atlantic Hematological Oncology Center, Morristown, NJ
Acute Myeloid Leukemia+1 More ConditionsCG-806 - Drug
Eligibility
18+
All Sexes

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.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

3 Primary · 14 Secondary · Reporting Duration: At the end of Cycle 1 (each cycle is 28 days)

Day 28
Compare G1 to G3 Pharmacokinetics variables including clearance
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
Pharmacokinetics variables including area under the curve (AUC)
Pharmacokinetics variables including clearance
Pharmacokinetics variables including maximum plasma concentration (Cmax)
Pharmacokinetics variables including maximum plasma concentration (Cmax).
Pharmacokinetics variables including minimum plasma concentration (Cmin)
Pharmacokinetics variables including plasma half-life.
Pharmacokinetics variables including serum half-life
Pharmacokinetics variables including volume of distribution
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
To assess patients for evidence of anti-tumor activity of CG-806 based on hematologic, bone marrow, physical examination, evaluations
To determine the Relative Bioavailability of Generation 3 formulation given to up to 18
To determine the Relative Bioavailability of Generation 3 formulation given to up to 18 patients on Cycle 1 Day -3 compared to Generation 1 formulation of study drug given to patients during Cycle 1.
To determine the ability of CG-806 to modulate the expression or activity of pharmacodynamic biomarkers of drug effect.

Trial Safety

Phase-Based Safety

1 of 3

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Dose Escalation and Expansion
1 of 1

Experimental Treatment

80 Total Participants · 1 Treatment Group

Primary Treatment: CG-806 · No Placebo Group · Phase 1

Dose Escalation and Expansion
Drug
Experimental Group · 1 Intervention: CG-806 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at the end of cycle 1 (each cycle is 28 days)

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

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to swallow pills.
Your kidneys, liver, and heart are working well enough for you to participate in the study.
You are expected to live for at least three more months.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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