NL-OMON36240已完成不适用
A phase I, multicenter, open-label dose escalation study of LDK378, administered orally in adult patients with tumors characterized by genetic abnormalities in anaplastic lymphoma kinase(ALK) - A phase I study with LDK378 in tumors with ALK mutation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patients with tumors characterized by abnormalities in ALK (translocation or mutation).
- •2. ECOG performance status * 2
- •3. Laboratory:
- •-Absolute Neutrophil Count *1.5x109/L
- •- Hemoglobin * 9 g/dl <= 5.58 mmol/l
- •- Platelets *100x109/L
- •- Total bilirubin * 1.5 x upper limit of normal (ULN)
- •- Alkaline phosphatase, AST (SGOT) and ALT (SGPT) * 2.5 x ULN, with liver metastasis *5 x ULN
- •- Creatinine * 1.5 x ULN or calculated creatinine clearance * 50 mL/min (* 0.835 mL/s)
- •- Amylase * ULN
- •- Lipase * ULN
- •- Fasting plasma glucose * 200 mg/dL (* 11.1 mmol/L)
排除标准
- •1. Central nervous system (CNS) metastases which are unstable, symptomatic and require increasing doses of steroids to control the disease.
- •2. Unresolved nausea, vomiting or diarrhea > CTCAE grade 1
- •3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of LDK378
- •4. History of pancreatitis or history of increased amylase or lipase
- •5. Acute or chronic liver disease. Evidence of previous hepatitis viral infection (testing is not mandatory)
- •6. Clinically significant cardiac disease including congestive heart failure (New York Heart Association Class III or IV), arrhythmia or conduction abnormality requiring medication, or cardiomyopathy; or clinically uncontrolled hypertension (blood pressure > 160/110 mmHg)
- •7. Impaired cardiac function, including:
- •- Complete left bundle branch block
- •- Cardiac pacemaker
- •- Congenital long QT syndrome
- •- History or presence of ventricular tachyarrhythmia
- •- Presence of unstable atrial fibrillation (ventricular response > 100 bpm
- •- Clinically significant resting bradycardia (< 50 bpm)
- •- Corrected QTcF > 450 msec for males and > 470 msec for females at screening
- •- PR * 240 msec and QRS * 110 msec
- •- Right bundle branch block + left anterior hemiblock (bifascicular block)
- •- Angina pectoris and Acute Myocard Infarction * 3 months prior to starting study drug
- •8. Other concurrent severe and/or uncontrolled medical conditions
- •9. Prior treatment with chemotherapy or biologic therapy or other investigational agent < 5x t1/2 or < 2 weeks (whichever is longer) prior to starting study drug . If prior treatment was crizotinib, LDK378 may start 2 weeks after the last dose.
- •10. Unresolved toxicity greater than CTCAE grade 1 from previous anti-cancer therapy or radiotherapy (excluding neurotoxicity, alopecia, ototoxicity, lymphopenia)
- •11. Radiotherapy * 3 weeks
- •12. Major surgery * 2 weeks
- •13. Strong inhibitors or inducers of CYP3A4/5
- •14. CYP2C9: warfarin and phenytoin
- •15. Coumarin-type anticoagulants. Treatment with maximum daily dose of 2 mg of coumarin-type anticoagulants for line patency is permitted. Low molecular weight heparin is permitted.
研究者
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