EUCTR2013-000773-71-DK进行中（未招募）1 期
A multicenter phase II study evaluating the efficacy and tolerability of vemurafenib in combination with Pegylated Interferon and Interleukin-2 in patients with BRAF-mutated metastatic melanoma - vem+IL-2
Department of Oncology, Aarhus University Hospital0 个研究点目标入组 50 人开始时间: 2013年7月12日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •Histologically verified unresectable stage III or stage IV melanoma with documented BRAF V600 mutation determined by the cobas® 4800 BRAF mutation test
- •Age between 18 and 70
- •ECOG performance status (PS) 0-2
- •Patients must have measurable target lesions disease as defined by RECIST v1.1
- •Prior medical treatment for metastatic melanoma is allowed, except previous treatment with BRAF-inhibitor and IL-2 based immunotherapy
- •Adequate cardiac function (less or equal to NYHA II). In the case of previous myocardial infarction echocardiography or MUGA-scan must be performed and left ventricle ejection fraction must be found normal
- •Adequate hematologic, renal and liver function as defined by laboratory values performed within 2 weeks of enrolment:
- •oAbsolute neutrophil count (ANC) = 1.5 x 109/L
- •oPlatelet count = 100 x 109/L
- •oSerum creatinine = 1.5 times upper limit of normal (ULN) or - creatinine clearance (CrCl) > 50 mL/hr by Cockroft–Gault formula
- •oAlanine aminotransferase (ALAT) = 2.5 times ULN (= 5 times ULN if considered due to liver metastasis)
- •oSerum bilirubin = 1.5 times ULN
- •oAlkaline phosphatase = 2.5 times ULN (= 5 times ULN if considered due to liver metastasis)
- •Patients must have absence of any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of the study drugs hazardous or obscure the interpretation of adverse events
- •Fertile men and women must be using an effective method of contraception during treatment and for at least one month after completion of treatment
- •Women of child-bearing potential (WOCBP) must have a negative pregnancy test (HCG-urinalysis) before trial entry
- •Signed informed consent must be obtained prior to performing any study-related procedures. Testing for the V600 BRAF-mutation is considered as a standard procedure
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Any known severe and symptomatic autoimmune diseases that upon the opinion of the Investigators may conflict with the administration of the study medication.
- •Cerebral metastases. Patients that have been radically treated (neurosurgery or stereotactic radiotherapy) for a solitary cerebral metastasis may be included if MRI of the brain performed at least one month after treatment is without evidence of disease activity
- •Patients must not be dependent on systemic treatment with corticosteroids or other immunosuppressing agents
- •Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that may compromise adequate absorption. Patients must be able to swallow tablets
- •Uncontrolled infectious disease (requiring treatment with intravenous antibiotics)
- •Second malignancy in the past 5 years with the exception of surgically cured carcinoma in situ of the cervix or basal and squamous cell carcinoma of the skin.
- •QTc-interval > 500 ms
- •Any psychological, familial, sociological or geographical condition that upon the opinion of the investigators may affect the compliance with the protocol and follow-up schedule
研究者
相似试验
招募中
不适用
A Multi-center Phase II Study evaluating efficacy and safety of Dasatinib in Patients with newly diagnosed Philadelphia(Ph) chromosome positive Chronic Myeloid Leukemia in chronic phase.Chronic Myeloid LeukemiaJPRN-UMIN000005843Epidemiological and Clinical Research Information Network (ECRIN)30
进行中（未招募）
不适用
Phase II multicentric study to evaluate the efficacy and the safety of Bendamustine in adjunct to Etoposide, Aracytabin and Melphalan (BeEAM) as a preparative regimen for autologous stem cell transplantation in refractory/relapsed lymphoma patients. - BeEAMDiagnosis of Non-Hodgkin lymphoma of any subtype, chronic lymphocytic leukemia, or Hodgkin disease either refractory or relapsed after at least one line of chemotherapy.MedDRA version: 9.1Level: HLGTClassification code 10025320MedDRA version: 9.1Level: HLGTClassification code 10025319EUCTR2008-002736-15-ITAZIENDA OSPEDALIERA OSPEDALE S. SALVATORE
进行中（未招募）
不适用
study to evaluate the efficacy of a preparative regimen for transplantation in refractory/relapsed non-Hodgkin lymphoma patients.Adult agressive B-cell non-Hodgkin lymphoma patients.MedDRA version: 14.1Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 14.1Level: PTClassification code 10012821Term: Diffuse large B-cell lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 14.1Level: PTClassification code 10012822Term: Diffuse large B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-001246-14-ITAZIENDA OSPEDALIERA OSPEDALE S. SALVATORE
已完成
2 期
Multicenter Phase II study to evaluate efficacy and safety of combination therapy with trastuzumab and pertuzumab in patients with HER2-positive metastatic colorectal cancercolorectal cancerJPRN-UMIN000027887ational Cancer Center Hospital East30
进行中（未招募）
不适用
A multicenter phase II study to determine the efficacy of capecitabine as first line monochemotherapy in patients with HER2 negative, medium-risk, metastatic breast cancer - Monica StudyEUCTR2005-000074-51-DEGBG Forschungs GmbH