Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385177
Status:
COMPLETED
Last Update Posted:
2009-06-04
First Post:
2006-10-03
Brief Title:
Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors
Sponsor:
Achieve Life Sciences
Organization:
Achieve Life Sciences
Study Overview
Official Title:
A Multicenter Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2009-06
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 open-label study of SN2310 Injectable Emulsion in patients with advanced solid malignancies The study is designed to determine the maximum tolerated dose and dose-limiting toxicity of SN2310 Injectable Emulsion and to characterize the pharmacokinetics of SN2310 and SN-38 following intravenous administration of SN2310 Injectable Emulsion Additionally evaluation of side effects as a function of dose and observation of any anti-tumor effects of SN2310 Injectable Emulsion will be made
Detailed Description:
This is a Phase 1 open-label study of SN2310 Injectable Emulsion in patients with advanced solid malignancies who have failed conventional therapy SN2310 Injectable Emulsion will be administered intravenously every 21 days The study is designed to determine the maximum tolerated dose and dose-limiting toxicity of SN2310 Injectable Emulsion to characterize the pharmacokinetics of SN2310 and SN-38 following intravenous administration of SN2310 Injectable Emulsion to evaluate side effects as a function of dose level and to observe any anti-tumor effects of SN2310 Injectable Emulsion
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