ACTRN12610000897066
Terminated
N/A
The utility of genomics and functional imaging to predict Sunitinib pharmacokinetics and pharmacodynamics: The PREDICT SU Study
Peter MacCallum Cancer Centre0 sites70 target enrollmentOctober 21, 2010
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Metastatic renal cell carcinoma (RCC)
- Sponsor
- Peter MacCallum Cancer Centre
- Enrollment
- 70
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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