EUCTR2012-004539-22-IT进行中（未招募）不适用
An open label, single arm, phase II study to evaluate the activity and toxicity of Panitumumab in pre-treated patients with advanced well differentiated neuroendocrine tumor (G1 and G2) - Panitumumab and NETs
I.T.M.O. - ITALIAN TRIALS IN MEDICAL ONCOLOGY0 个研究点开始时间: 2013年1月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Histological diagnosis of well-differentiated neuroendocrine tumor (G1 and G2) of gastro-entero-pancreatic district or of unknown primary site. •Disease progression after treatment with somatostatin analogues •Previous treatment with everolimus, sunitinib or bevacizumab is admitted. •One chemotherapy is admitted. •Metastatic or locally advanced disease. •Male or female, age > 18 years. •Absence carcinoid syndrome. •ECOG performance status 0-1. •Expectancy of life > 6 months •Written informed consent •Adequate liver function as shown by: serum bilirubin =1.5 x ULN; ALT and AST < 2.5x ULN (< 5x ULN in patients with liver metastases) •Adequate bone marrow function: ANC > 1.5 x 109/L;PLT > 100 x 109/L; Hb > 9 g/dL •Creatinine clearance > 50 ml/min •Magnesium and calcium > lower limit of normal •At least one measurable lesion at CT scan as defined by RECIST •Women of childbearing potential must have had a negative serum or urine pregnancy test within 7 days prior to the administration of the study treatment start, and must use an acceptable form of contraception
- •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 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •Patients with a known hypersensitivity to panitumumab •Histological diagnosis of poorly differentiated neuroendocrine carcinoma (G3) •Histological diagnosis of lung neuroendocrine tumors (typical or atypical carcinoid, small cell lung cancer, large cell neuroendocrine carcinoma) •Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction = 12 months prior to first study treatment, serious uncontrolled cardiac arrhythmia; severely impaired lung function; uncontrolled diabetes; any active (acute or chronic) or uncontrolled infection/disorders that impair the ability to evaluate the patient or for the patient to complete the study; non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study treatment, such as severe hypertension that is not controlled with medical management and thyroid abnormalities due to which thyroid function cannot be maintained in the normal range by medication; liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis or chronic persistent hepatitis; fatal or life-threatening autoimmune and ischemic disorders; uncontrolled hyperlipidemia •History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. •Patients with serious neurological or psychiatric disorders •Patients with central nervous system (CNS) metastases •Patients who have a history of another primary malignancy with the exception of basal or squamous cell skin cancer, in situ cancer, and any cancer from which the patient has been disease free for 5 years •Immunocompromised patients, including positive HIV test. An HIV test is not required to enter the study •Female patients who are pregnant or breast feeding •Patients of reproductive potential who are not using appropriate contraceptive methods. Appropriate forms of contraception are: IUD, oral or depot contraceptive or the barrier method plus spermicide.
研究者
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