Ignite Creation Date:
2024-05-06 @ 12:09 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01505153
Status:
COMPLETED
Last Update Posted:
2018-02-22
First Post:
2012-01-04
Brief Title:
Phase I Intratumoral Pbi-shRNA STMN1 LP in Advanced andor Metastatic Cancer
Sponsor:
Gradalis Inc
Organization:
Gradalis Inc
Study Overview
Official Title:
Phase I Trial of Intratumoral Bi-functional shRNA Stathmin 1-knockdown Lipoplex in Patients With Advanced andor Metastatic Cancer
Status:
COMPLETED
Status Verified Date:
2018-02
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:
STMN1-LP
Brief Summary:
This is a Phase I safety trial of bifunctional shRNA-STMN1 pbi-shRNASTMN1 BIV bilamellar invaginated vesicle lipoplex LP pbi-shRNA STMN1 LP administered by a single intratumoral IT injection Patients with superficially accessible advanced cancer following prior therapies will be entered into the study following a modified dose escalation design based on the demonstrated safety of our previous clinical experience BB-IND 13744 with the same liposome and vector DNA backbone expressing a different transgene of which doses up to 7 mg DNA IVsingle dose have been administered Patients will accrue in 4-patient escalation cohorts using a modified Fibronacci escalation schema 100-50-33-33 at a starting intratumoral dose of 0010 mgkg of DNA through a dose of 0053 mgkg DNA intratumoral single dose Should a single but not more than two 2 Grade 3 Dose Limiting Toxicity DLT occur in any cohort following mandated review see below an additional two 2 patients will be accrued at that dose total of six If more than one Grade 3 toxicity occurs in any cohort the preceding dose cohort will be expanded to six from four and if 26 patients experience Grade 3 toxicity that dose will be the Phase II recommended dose Should no Grade 3 toxicity occur in any cohort other than Grade 3 local injection site reaction an additional two 2 patients will be treated at 0053 mgkg DNA intratumoral single dose
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