drugset / Trial / NCT03564288

Study to Find a Safe and Effective Dose of SKI-G-801 in the Treatment of Patients With Acute Myeloid Leukemia (AML)

NCT03564288 ↗

Phase 1 Completed 14 enrolled Oscotec Inc. PPD Development, LP · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-02-23
Primary completion
2021-09-02
Completion
2021-09-02

Drugs

EvaluationDrugModalityDoseRoute
Subject SKI-G-801 Unknown — Intravenous