Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001693
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Phase I-II Multiple-Dose Safety and Efficacy Study of a Selective Inhibitor of Cyclooxygenase - 2 SC-58635 in Hereditary Non-Polyposis Colorectal Cancer HNPCC Patients and Carriers
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I-II Multiple-Dose Safety and Efficacy Study of a Selective Inhibitor of Cyclooxygenase - 2 SC-58635 in Hereditary Non-Polyposis Colorectal Cancer HNPCC Patients and Carriers
Status:
COMPLETED
Status Verified Date:
2002-01
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:
This is a randomized placebo-controlled Phase III multi-center trial of the safety and efficacy of Celecoxib in a cohort of 81 HNPCC subjects and gene carriers The three proposed intervention arms are Celecoxib to be provided by Searle will be administered at 200mg po BID x 12 months or 400mg po BID x 12 months vs Placebo po BID x 12 months Assessment of endoscopic and tissue-based biomarker endpoints will be conducted at baseline and 12 months on study drug or placebo Patients that present with polyps at baseline will undergo a month 4 endoscopy Plasma drug trough samples for pharmacokinetic analyses will be collected at baseline and month 12 NCI-Chemoprevention Branch will coordinate the efforts and activities of all sites
Safety monitoring will occur via in-patient interviews with exams at month twelve symptom questionnaires completed at baseline months one four eight and twelve blood and urinalysis at baseline and at months one four eight and twelve A post-administration telephone call to evaluate side effect resolution will occur at months 13-14 for patients who have unresolved adverse events at the end of month 12
Safety monitoring will occur via in-patient interviews with exams at month twelve symptom questionnaires completed at baseline months one four eight and twelve blood and urinalysis at baseline and at months one four eight and twelve A post-administration telephone call to evaluate side effect resolution will occur at months 13-14 for patients who have unresolved adverse events at the end of month 12
Detailed Description:
This is a randomized placebo controlled Phase III multi-center trial of the safety and efficacy of Celecoxib in a cohort of 81 HNPCC subjects and gene carriers The three proposed intervention arms are Celecoxib to be provided by Searle will be administered at 200 mg po BID x 12 months or 400 mg po BID x 12 months vs Placebo po BID x 12 months Assessment of endoscopic and tissue-based biomarker endpoints will be conducted at baseline and 12 months on study drug or placebo Patients that present with polyps at baseline will undergo a month 4 endoscopy Plasma drug trough samples for pharmacokinetic analyses will be collected at baseline and month 12 NCI-Chemoprevention Branch will coordinate the efforts and activities of all sites
Safety monitoring will occur via in-patient interviews with exams at month twelve symptom questionnaires completed at baseline months one four eight and twelve blood and urinalysis at baseline and at months one four eight and twelve A post-administration telephone call to evaluate side effect resolution will occur at months 13-14 for patients who have unresolved adverse events at the end of month 12
Safety monitoring will occur via in-patient interviews with exams at month twelve symptom questionnaires completed at baseline months one four eight and twelve blood and urinalysis at baseline and at months one four eight and twelve A post-administration telephone call to evaluate side effect resolution will occur at months 13-14 for patients who have unresolved adverse events at the end of month 12
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 |
|---|---|---|---|
| 98-C-0087 | None | None | None |