A phase I/II multicenter, open label study of TKI258 administered orally on an intermittent schedule in adult patients with advanced or metastatic Renal Cell Cancer (RCC) - Phase I/II study with TKI258 in RCC

ovartis0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•Patients that must have been previously treated with sunitinib and/or sorafenib and mTor inhibitor. However, patients previously treated with other therapies (e.g. IL-2, IF-*) are also allowed to be enrolled and treated to determine the effect of TKI258 in patients who had not been treated with VEGF receptor tyrosine kinase inhibitor and mTOR therapy.
•* Patients of Asian ethnicity: who failed standard treatment or for whom no standard therapy excists.
•* Patients with at least one measurable lesion at baseline as per the RECIST.
•* Serum creatinine * 1.5 x upper limit of normal (ULN)
•* Absolute neutrophil count (ANC) * 1.5 x 109/L
•* Platelets * 75 x 109/L
•* Hemoglobin * 4.96 mmol/l
•* Serum creatinine * 1.5 x upper limit of normal (ULN)
•* Bilirubin * 1.5 x ULN
•* AST (SGOT) and ALT (SGPT)* 2.5 x ULN, except for subjects with tumor
•involvement of the liver who must have AST and ALT * 5 x ULN
•* Amylase, Lipase * ULN
•* Electrolyte levels should be within normal limits
•* Urine dipstick: Negative for proteinuria or, if documentation of +1 results for protein on dipstick reading, then total urinary protein * 500 mg and measured creatinine clearance * 50 mL/min/1.73m2 from a 24-hour urine collection

•* Clinically significant cardiac disease (New York Heart Association, Class III or IV) or impaired cardiac function or clinically significant cardiac diseases, including any one of the following: LVEF < 45%, Complete left bundle branch block, use of a cardiac pacemaker, Congenital long QT syndrome, History or presence of ventricular tachyarrhythmia, unstable atrial fibrillation, Clinically significant bradycardia, Hypertension * Grade 2, QTc > 480 msec, Right bundle branch block + left anterior hemiblock (bifasicular block), Angina pectoris * 3 months prior to starting study drug, Acute Myocardial Infarction * 3 months prior to starting study drug.
•* Uncontrolled infection.
•* Diabetes mellitus with signs of clinically significant peripheral vascular disease.
•* Previous pericarditis; clinically significant pleural effusion in the previous 12 months or current ascites requiring two or more interventions/month
•* Known pre-existing clinically significant disorder of the hypothalamic-pituitary axis,
•adrenal or thyroid glands.
•* Prior acute or chronic pancreatitis
•* Acute and chronic liver disease and all chronic liver impairment.
•* Malabsorption syndrome or uncontrolled gastrointestinal toxicities with toxicity >NCI CTCAE grade 2.
•* Patients with brain metastases as assessed by radiologic imaging (e.g. CT, MRI)

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