Ignite Creation Date:
2024-05-05 @ 10:10 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01048320
Status:
COMPLETED
Last Update Posted:
2012-09-25
First Post:
2010-01-11
Brief Title:
Gemcitabine and Oxaliplatin Gem-Ox Plus Glivec in Gemcitabine-refractory Pancreatic Cancer
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Royal Marsden NHS Foundation Trust
Study Overview
Official Title:
A Phase I Study of Gemcitabine Plus Oxaliplatin in Combination With Imatinib Mesylate Glivec in Patients With Gemcitabine-refractory Advanced Adenocarcinoma of the Pancreas
Status:
COMPLETED
Status Verified Date:
2012-09
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:
RPGOG1
Brief Summary:
The main research objective is to work out the optimal doses of the novel combination of gemcitabine oxaliplatin and imatinib mesylate glivec in patients with advanced pancreatic cancer that has progressed during or after treatment with first-line gemcitabine
Detailed Description:
Using the phase I study design the dose of gemcitabine will be escalated in several steps to identify the highest tolerable dose that can be given safely Based on pre-defined dose-limiting toxicity the maximum tolerated dose of the combination will be identified and a safer dose for further evaluation of this regimen in pancreatic cancer selected The primary objectives are therefore based around safety of the drug combination
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 2005-004022-99 | None | None | None |