A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS (NCT04477291) | Clinical Trial Compass
TerminatedPhase 1
A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS
Stopped: Change in corporate strategy
United States45 participantsStarted 2020-10-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Age ≥18 years
* Life expectancy of at least 3 months
* ECOG Performance Status ≤ 2
* Patients must be able to swallow capsules
* Adequate hematologic parameters, unless cytopenias are disease caused
* Adequate renal, liver and cardiac functions
Key Exclusion Criteria:
* Patients with GVHD requiring systemic immunosuppressive therapy
* Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinically significant disease related metabolic disorder
* Clinically significant leukostasis
* Treatment with other investigational drugs or receipt of cytotoxic therapy within 14 days prior to first study treatment administration
* Receipt of cellular immunotherapeutic agents within 4 weeks prior to first study treatment administration
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of treatment-emergent adverse events of CG-806
Timeframe: At the end of Cycle 1 (each cycle is 28 days)
2
Establish a CG-806 dose that maintains a biologically active plasma concentration
Timeframe: At the end of Cycle 1 (each cycle is 28 days)
3
Establish a recommended dose for future development of CG-806
Timeframe: At the end of Cycle 1 (each cycle is 28 days)