Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT01282658
Status:
UNKNOWN
Last Update Posted:
2011-02-17
First Post:
2011-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacogenomics Study of CPT-11 as the First-line Chemotherapy for mCRC
Sponsor:
Huazhong University of Science and Technology
Organization:
Study Overview
Official Title:
Genetic Variants and the Efficacy or Severe Adverse Reactions of CPT-11 Based Regimens in mCRC
Status:
UNKNOWN
Status Verified Date:
2010-11
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:
PSIFL
Brief Summary:
Irinotecan (CPT-11) is now widely used as the first-line chemotherapy for mCRC. There were 4 key enzymes for CPT-11 metabolizing, CYP3A4, UDP-glucuronosyltransferase, carboxylesterase(CES), and ATP-binding cassette (ABC) transporters. Genetic variations of those enzymes may cause the heterogeneity in safety and efficacy of CPT-11. The aim of this study is to figure out the correlation between the genetic polymorphism and the drug response.
Detailed Description:
collect blood samples,determining genetic contribution to the safety and efficacy of CPT-11.
Study Oversight
Has Oversight DMC:
False
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?: