Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324610
Status:
UNKNOWN
Last Update Posted:
2006-05-18
First Post:
2006-05-09
Brief Title:
Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen
Sponsor:
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Organization:
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Study Overview
Official Title:
Phase III Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2006-05
Last Known Status:
RECRUITING
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:
Standard administration of capecitabine use a 14 days administration Routine practice in several intitution leads to use a 5 out of 7 days regimen with less toxicity
Purpose to compare the pharmacokinetics of capecitabine administered 5 days out of 7 as compared to the standard administration 14 days out of 21 The second end point is to compare toxicity with either regimen
Method Randomized study with two groups one with standard administration the second with 57 days regimen
Purpose to compare the pharmacokinetics of capecitabine administered 5 days out of 7 as compared to the standard administration 14 days out of 21 The second end point is to compare toxicity with either regimen
Method Randomized study with two groups one with standard administration the second with 57 days regimen
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 |
|---|---|---|---|
| ARTIC CAP 57 | None | None | None |