Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044785
Status:
TERMINATED
Last Update Posted:
2005-06-24
First Post:
2002-09-04
Brief Title:
Phase I Study of PN401 Fluorouracil Leucovorin and CPT-11 in Patients With Solid Tumors
Sponsor:
Wellstat Therapeutics
Organization:
Wellstat Therapeutics
Study Overview
Official Title:
A Phase I Study of Escalating Doses of CPT-11 and 5fluorouracil 5FU Plus PN401 With a Fixed Dose of Leucovorin in Patients With Solid Tumor Malignancies
Status:
TERMINATED
Status Verified Date:
2005-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
CPT-11 and 5Fluorouracil 5FU combined with leucovorin has become the standard of care for colorectal cancer PN401 permits treatment with higher than normal doses of 5FU which could increase its therapeutic potential It is hypothesized that adding PN401 to the CPT-11 5FU leucovorin regimen will reduce toxicity and will allow higher doses of 5FU to be well tolerated and therefore potentially increase effectiveness
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GCC0121 | None | None | None |