EUCTR2005-001316-47-FI进行中（未招募）不适用
Bevacizumab (Avastin™), dacarbazine and interferon a-2a (Roferon-A; IFN a-2a ) combination as a first-line therapy in patients with locally advancing or metastatic melanoma
Turku University Central Hospital0 个研究点目标入组 40 人开始时间: 2005年4月26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
- 入组人数
- 40
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 diagnosis of malignant melanoma either locally progressing inoperable or metastatic. Previous adjuvant therapy with interferon is allowed.
- •2.Age 18 or above
- •3.Measurable or evaluable disease in accordance with RECIST criteria
- •4.WHO performance status =2 and normal organ function
- •5.lab values in protocol
- •6.Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to the administration of the study drug. She and her partner should prevent pregnancy (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) up to at least 6 months after last treatment completion or the last drug dose, whatever happens first
- •7.Signed written informed consent according to ICH/GCP and the local regulations (approved by the Independent Ethics Committee [IEC]) will be obtained prior to any study specific screening procedures
- •8.Patient must be able to comply with the protocol
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Unevaluable disease
- •2.Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 0 (Patients must have recovered from any major surgery)
- •3.Planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed)
- •4.Clinical or radiological (CT) evidence of CNS metastases
- •5.Past or current history (within the last 5 years) of malignancies except for the indication under this study and curatively treated Basal and squamous cell carcinoma of the skin or In-situ carcinoma of the cervix
- •6.Serious non-healing wound or ulcer
- •7.Evidence of bleeding diathesis or coagulopathy
- •8.Uncontrolled hypertension
- •9.Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (= 6 months), myocardial infarction (= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
- •10.Evidence of serious depression or psychosis, which needs continuous medication.
- •11.Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications
- •12.Ongoing treatment with aspirin (> 325 mg/day) or other medications known to predispose to gastrointestinal ulceration (e.g. chronic use of non-steroidal anti-analgetics)
- •13.Pregnancy (positive serum pregnancy test) and lactation
- •14.Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
- •15.Previous chemotherapy for metastatic melanoma
研究者
相似试验
已完成
2 期
Bevacizumab, Dacarbazine and Interferon-Alfa to Treat Metastatic MelanomaMetastatic MelanomaNCT00308607University of Turku27
进行中（未招募）
1 期
Bevacizumab, Interleukin-2 and Interferon-alpha in metastathic renal cell carcinoma - mRCCEUCTR2009-012010-52-DKDepartment of Oncology, Aarhus University Hospital118
进行中（未招募）
不适用
Capecitabine and bevacizumab ± vinorelbine as 1st line treatment in HER2/neu-negative metastatic or locally advanced inoperable breast cancer patientsEUCTR2008-003779-37-DEiOMEDICO AG
进行中（未招募）
1 期
Evaluation of treatment combination Atezolizumab/Bevacizumab +/- Chemotherapy in patients with recurrent ovarian cancerEfficacy of atezolizumab in combination with non-platinum based chemotherapy and bevacizumab versus the combination of a non-platinum based chemotherapy and bevacizumab in recurrent ovarian cancerMedDRA version: 27.0Level: PTClassification code 10016182Term: Fallopian tube cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 27.0Level: PTClassification code 10057529Term: Ovarian cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-000202-37-LTAGO Research GmbH550
进行中（未招募）
1 期
Evaluation of treatment combination Atezolizumab/Bevacizumab +/- Chemotherapy in patients with recurrent ovarian cancerEUCTR2017-000202-37-NOAGO Research GmbH664