Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358566
Status:
TERMINATED
Last Update Posted:
2008-05-19
First Post:
2006-07-14
Brief Title:
GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer
Sponsor:
Pharmexa AS
Organization:
Pharmexa AS
Study Overview
Official Title:
Primovax - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer
Status:
TERMINATED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Preliminary data showed no survival benefit in the GV1001 group compared to the gemcitabine group
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas
Detailed Description:
The trial is a Phase III multinational multicentre controlled randomised open-label trial It will involve 520 advanced pancreatic cancer patients Patients will be randomly assigned to receive Gemcitabine alone or GV1001 plus GM-CSF followed by addition of Gemcitabine at the time of 1st progression of disease The experimental treatment is given prior to the current standard treatment in 50 of the patients
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Eudract no 2005-005014-21 | None | None | None |