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NCT04477291 · ClinicalTrials.gov registry record · Phase 1
A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS
A Phase 1 study, sponsored by Aptose Biosciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT04477291: Clinical Trial Phase 1 study, sponsored by Aptose Biosciences.
NCT04477291 is a Phase 1 study that was terminated before completion, run by Aptose Biosciences. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04477291, a Phase 1 study, was terminated before completion, sponsored by Aptose Biosciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
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.
Primary Outcome
Patients will be assessed for adverse events during all cycles of treatment and for dose limiting toxicities in Cycle 1 (28-days). Dose escalation to a higher dose level will be considered if none of the first three patients who complete Cycle 1 (28-days) at a given dose level experience a dose limiting toxicity or if only 1 of 6 patients at a given dose level experience a dose-limiting toxicity.
Interventions
- DRUG CG-806
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2020-10-06 |
| Est. Completion | 2024-04-15 |
| Phase | Phase 1 |
Why NCT04477291 stopped before completion
NCT04477291 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 1 intervention - of which CG-806 is the first listed.
NCT04477291 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04477291 about?
NCT04477291 is a clinical study titled "A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS". 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 ineli...
What is the current status of trial NCT04477291?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2020-10-06. Estimated completion is 2024-04-15.
What interventions are being tested in trial NCT04477291?
The interventions under investigation include: CG-806 (DRUG).
Who is sponsoring clinical trial NCT04477291?
This trial is sponsored by Aptose Biosciences, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04477291's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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