Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223899
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2005-09-13
Brief Title:
A Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma
Sponsor:
Vical
Organization:
Vical
Study Overview
Official Title:
A Phase 1 Multi-Center Open-Label Dose-Escalation Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2019-02
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:
None
Brief Summary:
To evaluate the safety of intratumorally injected VCL-IM01 at doses of 05 mg 1 tumor 15 mg 1 tumor 5 mg 1 tumor 10 mg 2 tumors 5 mg per tumor and 15 mg 3 tumors 5 mg per tumor followed by electroporation
Detailed Description:
Eligible subjects will receive intratumoral injections of VCL-IM01 followed by electroporation of the injected tumors
Subjects will be enrolled to receive one course of treatment A course of treatment is two cycles each cycle consisting of four weekly injectionelectroporation administrations followed by an observation period of two weeks
Subjects tumors will be evaluated at Screening at the end of Cycle 2 and at six months Week 26 from the initial drug administration
Subjects will be enrolled to receive one course of treatment A course of treatment is two cycles each cycle consisting of four weekly injectionelectroporation administrations followed by an observation period of two weeks
Subjects tumors will be evaluated at Screening at the end of Cycle 2 and at six months Week 26 from the initial drug administration
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