EUCTR2011-001550-29-DE进行中（未招募）1 期
Phase II/III randomized, double-blind study of Sandostatin LAR incombination with Axitinib versus Sandostatin LAR in combination withPlacebo in patients with progressive advanced G1-G2 (WHO 2010)neuroendocrine tumors of non-pancreatic origin
Grupo Español de Tumores Neuroendocrinos0 个研究点目标入组 253 人开始时间: 2016年10月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 253
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
- •1. Histologically confirmed G1-G2 neuroendocrine tumors (per WHO
- •2010 classification) of non-pancreatic origin, both functioning and nonfunctioning.
- •2. Metastatic or locally advanced disease not amenable to treatment
- •with curative intent.
- •3. Clinical or radiological progressive disease documented within 12
- •months prior to study entry.
- •4. Patient must have at least one measurable lesion as defined by
- •RECIST 1.1 criteria. Patients mustn?t have previously undergone
- •ablative local procedures (embolization, cryoablation, radiofrequency
- •ablation or others) within previous 6 months unless other target lesions
- •are present or imaging progression disease is clear after those
- •treatments (in these cases at least one month interval after local
- •treatment is required).
- •5. Ki-67less than 20%.
- •6. Prior treatment with somatostatin analogues permitted.
- •7. Prior interferon therapy allowed.
- •8. Up to two prior lines of systemic antineoplastic medical therapy
- •permitted other than SSA or IFN (such as chemotherapy or targeted
- •agents excluding those targeting VEGF/VEGFR). Treatment with SSA or
- •IFN does not count as prior lines of systemic antineoplastic therapy.
- •9. No prior VEGF- or VEGFR-targeted therapy allowed.
- •10. Adequate organ function, in terms of the values of :
- •? Absolute neutrophil count
- •? Platelet count
- •? Hemoglobin
- •? Alanine aminotransferase (ALT/SGPT) and aspartate
- •aminotransferase (AST/SGOT)
- •? Total serum bilirubin
- •? Serum creatinine or estimated creatinine clearance
- •? Proteinuria
- •11. Male or female, age above or equal 18 years.
- •12. ECOG performance status of 0-2.
- •13. Life expectancy of above 12 weeks.
- •14. At least 4 weeks since the end of prior systemic treatment with
- •resolution of all treatment-related toxicity to NCI CTCAE Version 4.0
- •grade less or equal to 1 or back to baseline except for alopecia or
- •adequately treated hypothyroidism.
- •15. No evidence of preexisting uncontrolled hypertension as
- •documented by 2 baseline blood pressure readings taken at least 1 hour
- •apart. Patients whose hypertension is controlled by antihypertensive
- •therapies are eligible.
- •16. Women (or their partners) should be sterilized by surgical methods
- •or be postmenopausal, or should be willing to use an effective
- •contraceptive method while they receive the study treatment and at
- •least for 6 month following. Women of childbearing potential must have
- •a negative serum or urine pregnancy test within 7 days prior to
- •treatment. Men (or their partners) should be sterilized by surgical
- •methods or should be willing to use an effective contraceptive method
- •while they receive the study treatment and at least for 6 month
- •following. The definition of an effective contraceptive method should be
- 另有 14 项未显示
排除标准
- •1.The following endocrine tumor types may not be included: paraganglioma, adrenal, thyroid, parathyroid or pituitary endocrine tumors.
- •2.Major surgery in <4 weeks or radiation therapy <2 weeks prior to starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
- •3.Gastrointestinal abnormalities including:
- •a.inability to take oral medication;
- •b.requirement for parenteral nutrition;
- •c.prior surgical procedures affecting absorption including total gastric resection;
- •d.active peptic ulcer disease in the past 6 months;
- •e.active gastrointestinal bleeding, unrelated to cancer, as evidenced by
- •hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy;
- •f.malabsorption syndromes.
- •4.Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine)unless it can be replaced by other drugs with minimal inhibition potential of CYP3A4/5. Low dose oral steroid therapy is allowed (< 5 mg/day or prednisone or equivalent). Co-administration may increase plasma concentrations of axitinib.
- •5.Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St.John's wort), unless it can be replaced by other drugs with minimal induction potential of CYP3A4. Co-administration may decrease plasma concentrations of axitinib
- •6.Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.
- •7. History of relevant haemorrhage within the past 6 months, including
- •gross hemoptysis or hematuria. Except is caused by a trated cause
- •8.Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis.
- •9.A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment.
- •10.Any of the following within the 12 months prior to study drug administration:
- •myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
- •11. Ongoing cardiac dysrhythmias of NCI CTCAE grade > 2, atrial
- •fibrillation of any grade, or QTc interval >450 msec for males or >470
- •msec for females.
- •12.Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- •13.History of a malignancy (other than renal cell cancer) except those treated with curative intent for skin cancer (other than melanoma), in situ breast or in situ cervical cancer, or those treated with curative intent for any other cancer with no evidence of disease for 5 years.
- •14.Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and
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