The use of non invasive methods to predict drug handling and toxicity of Sunitinib

Not Applicable

• Conditions: Metastatic renal cell carcinoma (RCC); Metastatic Gastrointestinal Stromal Tumuor (GIST); Cancer - Kidney; Cancer - Other cancer types

• Registration Number: ACTRN12610000897066
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: Observational
• Study Design: Not specified