Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-02-21 @ 9:44 AM
Study NCT ID:
NCT01700335
Status:
COMPLETED
Last Update Posted:
2022-11-21
First Post:
2012-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Pharmacokinetics Study of SyB L-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS)
Sponsor:
SymBio Pharmaceuticals
Organization:
Study Overview
Official Title:
Phase I Clinical Trial of SyB L-1101 in Patients With Myelodysplastic Syndrome
Status:
COMPLETED
Status Verified Date:
2022-10
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:
The purpose of this study is to investigate tolerability when SyB L-1101 is administered intravenously in patients with recurrent/relapsed or refractory myelodysplastic syndrome, to determine the dose-limiting toxicity and maximum tolerated dose, and to estimate the recommended dose for phase II studies. Pharmacokinetics and antitumor effects will also be investigated.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: