Ignite Creation Date:
2024-05-06 @ 12:14 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01523431
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2012-01-19
Brief Title:
Individual Dosage Selection of Irinotecan CPT-11 Based on UGT1A1 Genotype in Metastatic Colorectal Cancer Patients
Sponsor:
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Organization:
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Study Overview
Official Title:
Influence of Individual Dosage Selection of Irinotecan CPT-11 Based on UGT1A1 Genotype on Clinical Outcomes and Pharmacokinetics in Chinese Patients With Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2017-03
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:
The purpose of this study is to investigate the influence of dose selection of CPT-11 on toxicity response and pharmacokinetics according to UGT1A1 genotype in colorectal cancer patients
Detailed Description:
Genetic polymorphisms of UGTs result in reduced enzyme activity and increased toxicity UGT1A128 and UGT1A16 are reported to increase CPT-11-related toxicity in Asian patients Moreover the area under concentration curve AUC ratio of SN-38G to SN-38 is decreased in Asian patients having UGT1A1 28 or UGT1A16 This implicated that the current standard dose of CPT-11 would be overdosing for homozygous UGT1A12828 66 or 286 patients
The study is designed to investigate the role of prospectively dose reduction of CPT-11 in toxicity tumor response and pharmacokinetics for homozygous UGT1A1 patients and compare these parameters to standard dose of CPT-11 for wild-type heterozygous or homozygous UGT1A1 patients
The study is designed to investigate the role of prospectively dose reduction of CPT-11 in toxicity tumor response and pharmacokinetics for homozygous UGT1A1 patients and compare these parameters to standard dose of CPT-11 for wild-type heterozygous or homozygous UGT1A1 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None