Phase I Study to Investigate Genotype-based Dose Individualization of Irinotecan in Asian Cancer Patients
OBJECTIVES:
Primary
- To determine the dose-limiting toxicity and maximum tolerated dose of irinotecan
hydrochloride according to the genotype status of Asian patients with solid tumors.
Secondary
- To investigate the pharmacokinetics of irinotecan hydrochloride and its metabolites
SN-38 and SN-38G.
- To evaluate time to tumor response, response duration, and time to progression in these
patients.
OUTLINE: Patients are stratified according to genotype status (UGT1A1*28 vs UGT1A1*6)
Patients receive irinotecan hydrochloride IV once weekly for 3 weeks. Treatment repeats
every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable
toxicity.
Patients undergo blood sample collection periodically for pharmacogenetic, pharmacokinetic,
and pharmacodynamic studies.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicity
No time frame defined. Trial is still recruiting.
Yes
Su Pin Choo, MD
Principal Investigator
National Cancer Centre, Singapore
Singapore: Health Sciences Authority
CDR0000601207
NCT00731276
June 2008
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