Ignite Creation Date:
2024-05-06 @ 1:24 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01809912
Status:
TERMINATED
Last Update Posted:
2015-11-26
First Post:
2012-10-30
Brief Title:
Safety Study of MG1102 in Patients With Solid Tumors
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
A PHASE 1 OPEN LABEL DOSE ESCALATION STUDY TO INVESTIGATE THE SAFETY TOLERABILITY AND PHARMACOKINETICS OF MG1102 IN PATIENTS WITH SOLID TUMORS
Status:
TERMINATED
Status Verified Date:
2014-01
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:
To investigate the safety and tolerability of a 28 day course of intravenous IV MG1102 in patients with solid tumors for which no standard therapy is available
Detailed Description:
This is an open-label Dose Escalation Study multicenter phase I study to evaluate the safety and tolerability determine the pharmacokinetics and obtain preliminary information regarding pharmacodynamics and efficacy of MG1102 in subjects with solid tumor
Each subject will receive on dose of MG1102 followed by a 6-day rest period If the initial dose is tolerated subject will continue with the 21 days of MG1102 administration 5 days on treatment 2 days off treatment for 3 weeks Subjects that have a tumor response as stable disease may continue therapy on a compassionate use
Study Duration for a minimum of 8 weeks
Each subject will receive on dose of MG1102 followed by a 6-day rest period If the initial dose is tolerated subject will continue with the 21 days of MG1102 administration 5 days on treatment 2 days off treatment for 3 weeks Subjects that have a tumor response as stable disease may continue therapy on a compassionate use
Study Duration for a minimum of 8 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None