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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 is a Phase 1 study that has completed, run by Oscotec. The registered enrollment target is 14 participants.

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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.

Interventions

  • DRUG SKI-G-801

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2018-02-23
Est. Completion 2021-09-02
Phase Phase 1

Sponsor

Oscotec

6 total trials

What the Registry Record Tells You About NCT03564288

The ClinicalTrials.gov registry entry for NCT03564288 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oscotec, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which SKI-G-801 is the first listed.

NCT03564288 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.