EUCTR2004-002130-18-AT进行中（未招募）不适用
A Phase 1/2 , Multi-Center, Blinded, Randomized, Controlled Study of the Safety and Efficacy of the Human Monoclonal Antibody to Human av Integrins (CNTO 95), Alone and in Combination with Dacarbazine, in Subjects with Stage IV Melanoma
Centocor B.V.0 个研究点目标入组 120 人开始时间: 2007年1月17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
- 入组人数
- 120
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
- •- Male or female = 18 years
- •- Provide signed informed consent(s) prior to any study specific-procedures and agree to comply with all protocol-specified procedures
- •- Histologically confirmed melanoma
- •- AJCC Stage IV melanoma
- •- Radiographically measurable disease (at least 1 measurable lesion as defined by RECIST) or measurable skin lesion
- •- Previously untreated for metastatic melanoma by chemotherapy
- •- ECOG performance status = 2
- •- Life expectancy of = 12 weeks
- •- At least 4 weeks from prior major surgery to date of first study agent administration. Subjects must have recovered or stabilized from prior surgery
- •- Women of childbearing potential must be using adequate birth control measures (eg, oral contraceptives, complete abstinence, intrauterine device, barrier method with spermicide, or surgical sterilization) and not be breast-feeding, and men must be using barrier contraception with spermicide. Subjects must agree to continue such precautions for 6 months after the last administration of study agent. Women of childbearing potential must test negative for pregnancy at screening with a b-HCG serum pregnancy test
- •- Adequate bone marrow, liver, and renal function:
- •a. Neutrophils = 1500/mm3 (or = 1.5 billion/L)
- •b. Platelets = 100,000/mm3 (or = 100 billion/L)
- •c. Hemoglobin = 10.0g/dL (or = 100 g/L)
- •d. Bilirubin = 1.5 x upper limit of normal (ULN)
- •e. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) = 2.5 x ULN (= 4.0 x ULN with liver metastases)
- •f. Serum creatinine = 1.5 x ULN
- •g. Prothrombin time (PT)/international normalized ratio (INR) and activated partial thromboplastin time (aPTT) within normal range
- •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
- •- Prior chemotherapy for melanoma
- •- Received any investigational drug, systemic cancer therapy, or generalized radiation therapy within 30 days of date of first study agent administration
- •- History of receiving murine or human/murine recombination products of human alpha-v integrins
- •- History of anaphylaxis or severe allergic reaction(s) to mouse proteins or any components of CNTO 95
- •- Clinically important active infection
- •- Known human immunodeficiency virus (HIV) positively
- •- Presence of nonmeasurable lesions only (ie, bone metastases or malignant effusions)
- •- CNS metastases
- •- Prior radiation to target lesions (palliative radiation therapy to nontarget lesions is permitted)
- •- Concomitant or prior malignancy (other than the one under study) except adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancer for which the subject has been disease-free for = 5 years
- •- Concurrent immunotherapy, biotherapy, radiotherapy, chemotherapy, investigational therapy, or steroid therapy (except for topical and inhaled steroids, or unless clinically indicated [eg, reactions to IV contrast, allergic reactions that develop during the study, sever nausea and vomiting]) if planned to be given concomitantly
- •- Requires concurrent anticoagulation therapy (except for low dose prophylactic warfarin)
- •- History of bleeding diathesis
- •- Recurrent deep vein thrombosis (DVT) or DVT within the 6 months preceding treatment assignment/randomization
- •- Planned surgery (except for minor surgical procedures) during study period
- •- History of uveitis
- •- Any medical condition that, in the opinion of the investigator, may compromise the compliance of the subject to receive study treatment
- •- Requires hematopoietic growth factors or transfusion of blood products to meet eligibility criteria
研究者
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