The Pharmacogenetic and Pathological Assessment of CYP2C19 Activity in Patients with Advanced Cancer

Phase 1

• Conditions: Advanced cancer; Cancer -

• Registration Number: ACTRN12605000393651
• Lead Sponsor: Cancer Trials New Zealand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients with advanced cancer who last received cytotoxic or hormonal therapy for their cancer more than four weeks ago and who are being considered for a new line of therapy for disease progression or inadequate response to prior therapy; adequate renal and liver function; Patients must be able to provide informed consent

Exclusion Criteria

Patients receiving medication which is either a CYP2C19 inhibitor or inducer.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary aim of this exploratory study is to determine whether advanced cancer results in a decreased functional activity of CYP2C19, independent of genotype, as assessed by metabolism of a single dose of omeprazole[At 2 hours post administration]

Secondary Outcome Measures

Name	Time	Method
To determine whether decreased CYP2C19 function correlates with markers of disease severity as determined by circulating inflammatory cytokines (IL1, IL6 & TNF-α) and a marker of acute phase response, C-reactive protein.[]