None listed
Conditions
Brief summary
Suntinib is a drug with variable PK and toxicity profile that impacts upon its clinical use. This study will be targeted to patients receiving Sunitinib for the treatment of advanced renal cell cancer or GIST. Patients will have functional hepatic imaging and blood taken for pharmacogenomic studies of drug handling and drug target enzyme genes. During treatment patients will be monitored for response and toxicity and have bloods taken for steady state PK. We will then try to correlate PK, toxicity and response with liver imaging and genomic parameters in an attempt to develop doing nomograms.
Interventions
Standard treatment
Toxicity, response, Pharmacogenomics and Liver Imaging will be observed over 2 cycles of Sunitinib treatment (3 months).
Total duration of the study 4 years
Sponsors
Peter MacCallum Cancer Centre
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Cytologically/histologically proven advanced or metastatic renal cell carcinoma (RCC) or gastrointestinal stromal tumour (GIST) after failure of imatinib treatment due to resistance or intolerance with one or more measurable or evaluable lesions, adequate hepatic, bone marrow and renal function, Eastern Cooperative Oncology Group (ECOG) 2 or less life expectancy greater than 12 weeks, written informed consent for the study and its associated procedures. Patients that are to start Sunitinib therapy for the approved indications.
Exclusion criteria
Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol or compromises the patient's ability to give informed consent. Conditions that compromise oral absorption, any unresolved toxicity greater than NCI-CTC Grade 2 from previous anti-cancer therapy, co-administration of potent Cytochrome 3A4/5 inducers (phenytoin, carbamazepine, rifampicin, phenobarbitone, St John’s wort) 12 days prior to dosing, co-administration of potent Cytochrome 3A4/5 inhibitors (ketoconazole, erythromycin, clarithromycin, itraconazole, HIV antivirals and grapefruit juice) within 7 days of dosing, uncontrolled hypertension (BP >150/100mmHg despite optimal medical therapy), active bleeding disorders within the last 3 months, NYHA Grade III/IV cardiac problems (e.g. congestive heart failure, or myocardial infarction or active myocardial ischemia within 6 months of study), history of cerebrovascular accident including TIA or pulmonary embolism within 12 months, known diagnosis of human immunodeficiency virus (HIV) infection, active liver disease (e.g., chronic active hepatitis, cirrhosis), major surgery within 21 days prior to commencing study drugs
Outcome results
None listed