Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 5:43 PM
Study NCT ID:
NCT00005594
Status:
COMPLETED
Last Update Posted:
2011-01-04
First Post:
2000-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ISIS 2503 in Treating Patients With Advanced Cancer of the Pancreas
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
Phase II Trial of ISIS 2503, an Antisense Inhibitor of H-Ras, in Patients With Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2010-12
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:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of ISIS 2503 in treating patients who have advanced cancer of the pancreas.
PURPOSE: Phase II trial to study the effectiveness of ISIS 2503 in treating patients who have advanced cancer of the pancreas.
Detailed Description:
OBJECTIVES: I. Determine the response rate and time to progression in patients with advanced adenocarcinoma of the pancreas who are treated with ISIS 2503. II. Determine the duration of response in these patients receiving this regimen. III. Characterize the safety profile of ISIS 2503 at the recommended phase II dose and schedule in these patients.
OUTLINE: Patients receive ISIS 2503 IV continuously for 14 days. Treatment continues every 21 days for a minimum of 3 courses in the absence of unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: A total of 14-27 patients will be accrued for this study within 12 months.
OUTLINE: Patients receive ISIS 2503 IV continuously for 14 days. Treatment continues every 21 days for a minimum of 3 courses in the absence of unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: A total of 14-27 patients will be accrued for this study within 12 months.
Study Oversight
Has Oversight DMC:
True
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?: