Ignite Creation Date:
2024-05-06 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03564288
Status:
COMPLETED
Last Update Posted:
2024-02-21
First Post:
2018-05-03
Brief Title:
Study to Find a Safe and Effective Dose of SKI-G-801 in the Treatment of Patients With Acute Myeloid Leukemia AML
Sponsor:
Oscotec Inc
Organization:
Oscotec Inc
Study Overview
Official Title:
A Phase 1 Dose Escalation Trial of SKI-G-801 in Patients With Relapsed or Refractory Acute Myeloid Leukemia AML
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None