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NCT03564288 · ClinicalTrials.gov registry record · Phase 1
Study to Find a Safe and Effective Dose of SKI-G-801 in the Treatment of Patients With Acute Myeloid Leukemia (AML)
A Phase 1 study, sponsored by Oscotec.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT03564288: Completed Phase 1 study, sponsored by Oscotec.
NCT03564288 is a Phase 1 study that has completed, run by Oscotec. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03564288, a Phase 1 study, has completed, sponsored by Oscotec.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This Phase I study is designed to assess the safety, tolerability, pharmacokinetics and anti-tumor effect of increasing doses of study drug SKI-G-801 in patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are unresponsive to currently available therapies. Eligible participants will receive cycles of treatment involving IV infusion of SKI-G-801 daily for 14 days followed by 14 days off. Treatment cycles will be repeated until progressive disease or unacceptable toxicity.
Primary Outcome
RP2D of SKI-G-801 determined using Neuenschwander's continual reassessment method (N-CRM)
Interventions
- DRUG SKI-G-801
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-02-23 |
| Est. Completion | 2021-09-02 |
| Phase | Phase 1 |
What the finished NCT03564288 record still lists
NCT03564288 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which SKI-G-801 is the first listed.
NCT03564288 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03564288 about?
NCT03564288 is a clinical study titled "Study to Find a Safe and Effective Dose of SKI-G-801 in the Treatment of Patients With Acute Myeloid Leukemia (AML)". This Phase I study is designed to assess the safety, tolerability, pharmacokinetics and anti-tumor effect of increasing doses of study drug SKI-G-801 in patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are unresponsive to currently available therapies. Eligible participants will...
What is the current status of trial NCT03564288?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2018-02-23. Estimated completion is 2021-09-02.
What interventions are being tested in trial NCT03564288?
The interventions under investigation include: SKI-G-801 (DRUG).
Who is sponsoring clinical trial NCT03564288?
This trial is sponsored by Oscotec, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03564288's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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