Ignite Creation Date:
2024-05-05 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00710125
Status:
COMPLETED
Last Update Posted:
2014-08-05
First Post:
2008-07-02
Brief Title:
Safety Study of GPX-150 in Patients With Solid Tumors
Sponsor:
Gem Pharmaceuticals
Organization:
Gem Pharmaceuticals
Study Overview
Official Title:
Phase 1 Study and Dose Seeking Study of an Intravenous Formulation of the Anthracycline Analog GPX-150 in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2014-08
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 is a Phase 1 safety and dose escalation study to define the maximum tolerated dose MTD and identify the dose limiting toxicities DLT following IV administration of GPX-150 once every 3 weeks Escalating doses starting at the dose of 14 mgm2 and increasing to the dose of 265 mgm2 will be administered IV once every 3 weeks for up to 8 cycles of treatment Patients who have previously received an anthracycline are limited to 4 cycles of treatment
Detailed Description:
None
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