A Phase II Study of Pazopanib in Metastatic Merkel Cell Carcinoma - UKMCC-01, Version 1.0, 01-Jun-2012

niversity of Birmingham0 个研究点开始时间: 2012年7月30日最近更新: 2013年12月9日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: niversity of Birmingham

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Patients with histologically proven, unresectable, MCC that is metastatic and/or for which durable control cannot be achieved with surgery or radiotherapy
•RECIST measurable disease, as per RECIST version 1.1
•Age =18 years
•Performance status 0, 1 or 2 assessed using the Eastern Cooperative Oncology Group scale
•Received previous first line chemotherapy or considered unsuitable for chemotherapy
•Toxicities from first line chemotherapy resolved to at least grade 1
•Adequate end organ function
•o Renal function tests:
•- Serum creatinine =150 µmol/L. If serum creatinine >150 µmol/L, calculated creatinine clearance must be =30 ml/min
•- Urine Protein to Creatinine ratio (UPC) <1. If UPC =1, then a 24-hour protein must be assessed. Patients must have 24-hour protein value <1 g to be eligible. Alternatively, Albumin/Creatinine ratio may be measured (in accordance with institutional policy, same test to be used for study duration).
•o Liver function tests:
•- Total serum bilirubin =1.5 X Upper Limit Normal (ULN)
•- Alanine Aminotransferase or Aspartate Aminotransferase (in accordance with institutional policy, same test to be used for study duration) =2.5 X ULN (or =5 X ULN if liver metastases are present)
•o Haematology:
•- Absolute Neutrophil Count (ANC) =1.5 X 109/L
•- Haemoglobin =10 g/dL
•- Platelets =100 X 10 to the power of 9/L
•o Coagulation test:
•- International Normalized Ratio =1.2 X ULN, unless on therapeutic anti-coagulation. For patients on therapeutic anti-coagulation, INR should be stable and in target range.
•Able to give written informed consent
•Women of child-bearing potential, or men in a relationship with a woman of child- bearing age, prepared to adopt adequate contraceptive measures if sexually active
•Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

排除标准

•Previous malignancies. (Unless agreed in writing by the Chief Investigator or a clinical Co-investigator, investigators are advised to call the Trial Office).
•Known brain metastases unless radically treated with surgery or radiotherapy >6 months prior to study entry and without evidence of central nervous system progression since treatment
•History in the past 6 months of cerebral or clinically significant gastrointestinal haemorrhage
•Haemoptysis within 6 weeks prior to first dose of study medication
•Evidence of active bleeding or bleeding diathesis
•Uncontrolled hypertension defined as systolic blood pressure =140 mm Hg or diastolic blood pressure =90 mm Hg. Initiation or adjustment of antihypertensive medication(s) is permitted prior to trial entry
•Presence of uncontrolled infection
•History of malabsorption, major gastrointestinal tract resection or other pathology likely to affect absorption of study medication
•Prolongation of the QT interval (QTc) >480 milliseconds
•History of any one or more of the following cardiovascular conditions within the past 6 months:
•- Cardiac angioplasty or stenting
•- Myocardial infarction
•- Unstable angina
•- Coronary artery by-pass graft surgery
•- Symptomatic peripheral vascular disease
•- Class III or IV congestive heart failure, as defined by the New York Heart Association Functional Classification
•History of cerebrovascular accident including transient ischemic attack within the past 12 months
•History of pulmonary embolism or untreated deep venous thrombosis within the past 6 months. Patients with a history of thrombo-embolic disease who are on treatment with therapeutic anticoagulating agents are eligible
•Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
•Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drug chemically related to pazopanib
•Major surgery or trauma <4 weeks prior to starting study medication and/or presence of any non-healing wound, fracture, or ulcer
•Radiotherapy <2 weeks prior to starting study medication
•Known HIV, Hepatitis B or C infection
•Pregnant (female patients of child bearing potential should have a urine or blood Human Chorionic Gonadotropin test performed to rule out pregnancy prior to trial entry)
•Lactating females. Patients who agree to discontinue nursing 14 days prior to commencing treatment and do not nurse throughout all the treatment period are eligible
•The use of the following medication is prohibited:
•- Previous therapy with agents that target the Vascular Endothelial Growth Factor (VEGF) or Platelet-derived Growth Factor (PDGF) pathways
•- Chemotherapy, immunotherapy, biologic therapy, investigational therapy, hormone therapy or use of any prohibited medications within 14 days prior to the first dose of study medication
•- Use of drugs which are known strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose of study medication
•Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient’s safety, obtaining informed consent or compliance to the study
•Other contraindications to study medication

研究者

发起方

niversity of Birmingham

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