Phase I study of imatinib and LBH589 in imatinib- and sunitinib-refractory gastrointestinal stromal tumors - WTZ-GIST-09-01

niversitätsklinikum Essen0 个研究点目标入组 12 人开始时间: 2010年12月23日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Histologically proven diagnosis of GIST
•Objectively documented evidence of progressive disease according to modified RECIST criteria despite at least 2 months' continuous treatment with Imatinib at a dosage of 800 mg/day and progressive disease despite at least 3 months continous treatment with Sunitinib at 50mg/day (4 weeks on 2weeks off or 37.5mg continous dosing) or intolerance to each of the drugs at the above described dosing schedules. Patients with intolerance to imatinib at a dose of 800mg must have tolerated imatinib at the 400mg dose-level
•Adequate bone marrow, liver and renal function on imatinib treatment, as shown by: WBC = 3 x 109/L, Absolute neutrophil count (ANC) = 1.5 x 109/L, Hemoglobin = 9 g/dL, Platelet count = 100 x 109/L, Serum transaminase activity (AST/SGOT & ALT/SGPT) < 2.5 X ULN, Serum total bilirubin < 1.5 x ULN, Serum creatinine < 1.5 x ULN, or a creatinine clearance of = 60 mL/min.

•Patients presenting with known or symptomatic CNS metastases or leptomeningeal involvement
•History of cardiac disease: congestive heart failure (> New York Heart Association class 2), active coronary artery disease, cardiac arrhythmias requiring anti- arrhythmic therapy other than beta blockers or digoxin, uncontrolled hypertension; myocardial infarction more than 6 month prior to study entry is permitted. Patients that have received other HDAC-inhibitors alone or in combination with imatinib

发起方

niversitätsklinikum Essen