EUCTR2011-001550-29-ES进行中（未招募）不适用
A Phase II randomized double-blind study of Santostatin LAR in combination with Axitinib versus Placebo in patients with progressive advanced well-differentiated neuroendocrine carcinomas of non-pancreatic origin (carcinoids)
Grupo Español de Tumores Neuroendocrinos0 个研究点开始时间: 2012年1月24日最近更新:
适应症
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
- •1.Histologically confirmed well differentiated neuroendocrine carcinoma of non-pancreatic origin, either functional or non-functional tumors.
- •2.Metastatic or locally advanced disease not amenable to treatment with curative intent
- •3.Progressive disease documented in the prior 12 months (RECIST criteria 1.0)
- •4.Patients must have at least one measurable lesion as defined by RECIST criteria 1.0. Patients must not have undergone prior local-regional ablative procedures (embolization, cryoablation, radiofrequency ablation or other) within 6 months of study entry unless there are other sites of measurable disease or a clear radiological progression after performance of these procedures (in these cases, prior local-regional ablative procedures not permitted within 1 month of study entry).
- •5.Ki-67<20%
- •6.Prior treatment with somatostatin analogues permitted
- •7.Prior interferon therapy allowed
- •8.Two prior systemic antineoplastic therapy lines allowed (one of them may be an mTOR inhibitor)
- •9.No prior VEGF- or VEGFR-targeted therapy allowed
- •10.Adequate organ function as defined by the following criteria:
- •? absolute neutrophil count (ANC) ?1500 cells/mm3;
- •? platelets ?75,000 cells/mm3;
- •? hemoglobin ?9.0 g/dL;
- •? AST and ALT ?2.5 x upper limit of normal (ULN), unless there are liver
- •metastases in which case AST and ALT ?5.0 x ULN;
- •? total bilirubin ?1.5 x ULN;
- •? serum creatinine ?1.5 x ULN or calculated creatinine clearance ?60 mL/min;
- •? urinary protein <2+ by urine dipstick. If dipstick is ?2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is <2 g per 24 hours.
- •11.Male or female, age ?18 years.
- •12.ECOG performance status of 0-2.
- •13.Life expectancy of ?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 3.0 grade ?1 or back to baseline except for alopecia or hypothyroidism.
- •15.No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be ?150 mm Hg, and the baseline diastolic blood pressure readings must be ?90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
- •16.Female patients (or their couples) must be surgically sterile or be postmenopausal, or must agree to use effective contraceptive during the period of the trial and for at least 6 months after completion of treatment. All women at fertile age must have a negative pregnancy test (urine/serum) in the 7 days prior to the start of treatment. Male patients must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 6 months after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator or a designated associate. Breastfeeding women will not be able to participate in this study.
- •17.Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
- •18.Willingness and ability to comply with scheduled visits, treatment plans and study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) y
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). Low dose oral steroid therapy is allowed (< 5 mg/day or prednisone or equivalent)
- •5.Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St.John?s wort).
- •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 haemorrhage within the past 6 months, including gross hemoptysis or hematuria.
- •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 compliance with the requirements of this protocol.
- •15.Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patien
研究者
相似试验
进行中（未招募）
1 期
Randomized, double-blind study of Sandostatin LAR in combination withAxitinib compared with Sandostatin LAR in combination with Placebo inpatients with progressive advanced neuroendocrine tumors of nonpancreaticorigiPatients with progressive advanced well-differentiated neuroendocrine carcinomas of non-pancreatic origin (carcinoids)MedDRA version: 20.0Level: PTClassification code 10057270Term: Neuroendocrine carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-001550-29-DEGrupo Español de Tumores Neuroendocrinos253
进行中（未招募）
1 期
Randomized, double-blind study of Sandostatin LAR in combination with Axitinib compared with Sandostatin LAR in combination with Placebo in patients with progressive advanced neuroendocrine tumors of non-pancreatic origiEUCTR2011-001550-29-ITGETNE (GRUPO ESPAñOL DE TUMORES NEUROENDOCRINOS)253
进行中（未招募）
1 期
A double-blind, randomized phase II study of once daily versus twice daily PTK787/ZK 222584 treatment in patients with advanced, previously treated metastatic adenocarcinoma of the colon or rectum - Comparison of once daily versus twice daily administration of PTK787/ZK 222584 in mCRCEUCTR2006-004824-35-FRSchering AG
进行中（未招募）
不适用
A double-blind, randomized phase II study of once daily versus twice daily PTK787/ZK 222584 treatment in patients with advanced, previously treated metastatic adenocarcinoma of the colon or rectum - Comparison of once daily versus twice daily administration of PTK787/ZK 222584 in mCRCadvanced, previously treated metastatic adenocarcinoma of the colon or rectumMedDRA version: 8.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerEUCTR2006-004824-35-DESchering AG70
进行中（未招募）
不适用
A double-blind, randomized phase II study of once daily versus twice daily PTK787/ZK 222584 treatment in patients with advanced, previously treated metastatic adenocarcinoma of the colon or rectum - NDAdvanced, previously treated Metastatic adenocarcinoma of the colon or rectumMedDRA version: 9.1Level: LLTClassification code 10061045Term: Colon neoplasmEUCTR2006-004824-35-ITSCHERING66