Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004193
Status:
TERMINATED
Last Update Posted:
2013-04-12
First Post:
2000-01-21
Brief Title:
ISIS 2503 in Treating Patients With Metastatic andor Locally Recurrent Colorectal Cancer
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Phase II Trial of ISIS 2503 an Antisense Inhibitor of H-ras in Patients With Advanced Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2013-04
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:
RATIONALE ISIS 2503 may kill cancer cells by inhibiting a gene that promotes the development and growth of cancer
PURPOSE Phase II trial to study the effectiveness of ISIS 2503 in treating patients who have metastatic andor locally recurrent colorectal cancer
PURPOSE Phase II trial to study the effectiveness of ISIS 2503 in treating patients who have metastatic andor locally recurrent colorectal cancer
Detailed Description:
OBJECTIVES I Determine the response rate duration of response and time to progression in patients with metastatic andor locally recurrent adenocarcinoma of the colon or rectum treated with ISIS 2503 an antisense inhibitor of H-ras II Determine the safety profile of this regimen in these patients
OUTLINE This is a multicenter study Patients receive ISIS 2503 IV continuously for 14 days Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 14-25 patients will be accrued for this study within 1 year
OUTLINE This is a multicenter study Patients receive ISIS 2503 IV continuously for 14 days Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 14-25 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| NCI-G99-1649 | None | None | None |
| UAB-9860 | None | None | None |
| ISIS-2503-CS6 | None | None | None |