Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00300950
Status:
COMPLETED
Last Update Posted:
2015-04-06
First Post:
2006-03-08
Brief Title:
Safety and Efficacy of the Therapeutic Vaccine GI-4000 in Combination With Gemcitabine Versus Placebo for the Treatment of Non-metastatic Post-resection Pancreas Cancer
Sponsor:
GlobeImmune
Organization:
GlobeImmune
Study Overview
Official Title:
A Phase 2 Double-Blind Placebo Controlled Multi-center Adjuvant Trial of the Efficacy Immunogenicity and Safety of GI-4000 an Inactivated Recombinant Saccharomyces Cerevisiae Expressing Mutant Ras Protein Combined With a Gemcitabine Regimen Versus a Gemcitabine Regimen With Placebo in Patients With Post-resection R0R1 Pancreatic Cancer With Tumor Sequence Confirmation of Ras Mutations
Status:
COMPLETED
Status Verified Date:
2015-04
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:
The GI-4000 therapeutic vaccine or placebo will be injected under the skin of post-resection non-metastatic pancreas cancer patients Patients will be monitored for recurrence as well as safety and immune responses related to the injections
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