The effect of cancer progression on the activity of the liver enzyme called CYP2C19 in patients with carcinoma of the gastrointestinal tract using the probe drug proguanil.
Phase 1
- Conditions
- Carcinoma of the gastrointestinal tractCancer - Other cancer types
- Registration Number
- ACTRN12609000056291
- Lead Sponsor
- niversity of Auckland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Diagnosed with cancer
At least 18 years of age
Adequate renal and liver function
Serum creatinine =< 0.12 mg/L
Aspartate transaminase (AST), Alaninine transaminase (ALT) =< 2.0 X upper limit of normal (ULN) for institution
Alkaline phosphatase =< 2.5 X ULN
Total bilirubin =< ULN
Patients must be able to provide informed consent
Exclusion Criteria
Patients receiving medication which is either a CYP2C19 inhibitor or inducer, and where a washout period is not clinically feasible
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To elucidate the biological correlation between CYP2C19 functional activity and cancer progression in patients with carcinoma of the gastrointestinal tract at 3 hours post administration of proguanil.<br>CYP2C19 functional activity will be measured by plasma samples.Cancer progression is defined as per standard clinical practice.[At 3 hours post administration of proguanil]
- Secondary Outcome Measures
Name Time Method