NCT03564288

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 Dose Escalation Trial of SKI-G-801 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Oscotec Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	SKI-G-801	SKI-G-801 is administered as an IV infusion over 10 minutes

Timeline

• Start date: 2018-02-23
• Primary completion: 2021-09-02
• Completion: 2021-09-02
• First posted: 2018-06-20
• Last updated: 2024-02-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study