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NCT01265199 · ClinicalTrials.gov registry record · Phase 1
Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Properties of Oral AT-406 in Combination With Daunorubicin and Cytarabine in Patients With Poor-risk Acute Myelogenous Leukemia (AML)
A Phase 1 study, sponsored by Ascenta Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT01265199: Clinical Trial Phase 1 study, sponsored by Ascenta Therapeutics.
NCT01265199 is a Phase 1 study that was terminated before completion, run by Ascenta Therapeutics. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01265199, a Phase 1 study, was terminated before completion, sponsored by Ascenta Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
The main purpose of this study are to determine the maximum dose of AT-406 that can be safely given in combination with cytarabine and daunorubicin to humans. Other purposes are to determine how the drug is broken down in the body, and to see if there are any molecular interactions that can help determine how AT-406 works. Side effects will also be studied in an effort to make sure that this drug is safe to take.
Primary Outcome
Determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability of AT-101.
Interventions
- DRUG AT-406 in combination with daunorubicin and cytarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2011-02 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
Why NCT01265199 stopped before completion
NCT01265199 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 1 intervention - of which AT-406 in combination with daunorubicin and cytarabine is the first listed.
NCT01265199 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01265199 about?
NCT01265199 is a clinical study titled "Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Properties of Oral AT-406 in Combination With Daunorubicin and Cytarabine in Patients With Poor-risk Acute Myelogenous Leukemia (AML)". The main purpose of this study are to determine the maximum dose of AT-406 that can be safely given in combination with cytarabine and daunorubicin to humans. Other purposes are to determine how the drug is broken down in the body, and to see if there are any molecular interactions that can help det...
What is the current status of trial NCT01265199?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2011-02. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01265199?
The interventions under investigation include: AT-406 in combination with daunorubicin and cytarabine (DRUG).
Who is sponsoring clinical trial NCT01265199?
This trial is sponsored by Ascenta Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01265199's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 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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