EUCTR2004-002130-18-GB进行中（未招募）1 期
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 0 人开始时间: 2006年5月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
入选标准
- •1. Male or female = 18 years.
- •2. Provide signed informed consent(s) prior to any study specific-procedures and agree to comply with all protocol-specified procedures.
- •3. Histologically confirmed melanoma (including ocular and mucosal).
- •4. Documented AJCC Stage III unresectable or Stage IV melanoma (Phase 1); AJCC Stage IV melanoma (Phase 2).
- •5. Radiographically measurable disease (at least 1 measurable lesion as defined by RECIST) or measurable skin lesions.
- •6. Prior therapy:
- •a. In Phase 1, prior chemotherapy for metastatic melanoma is allowed.
- •b. In Phase 2, subjects previously untreated for melanoma by chemotherapy will be enrolled. Prior immunotherapy and biotherapy are permitted.
- •7. ECOG performance status = 2.
- •8. Life expectancy of = 12 weeks.
- •9. At least 4 weeks from prior major surgery to date of first study agent administration. Subjects must have recovered or stabilized from prior surgery.
- •10. 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 ß-HCG serum pregnancy test.
- •11. Adequate bone marrow, liver, and renal function:
- •a. Neutrophils = 1500/mm(3) (or = 1.5 × 10(9)/L).
- •b. Platelets = 100,000/mm(3) (or = 100 × 10(9)/L).
- •c. Hemoglobin = 10.0 g/dL (or = 100 g/L).
- •d. Bilirubin = 1.5 × upper limit of normal (ULN); (= 3.0 × ULN with liver metastases).
- •e. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) = 2.5 × ULN (= 5.0 × ULN with liver metastases).
- •f. Serum creatinine = 1.5 × 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
- •1. Prior chemotherapy for melanoma (Phase 2).
- •2. Received any investigational drug, systemic cancer therapy, or generalized radiation therapy within 30 days of date of first study agent administration.
- •3. History of receiving murine or human/murine recombination products of human a? integrins.
- •4. History of anaphylaxis or severe allergic reaction(s) to mouse proteins or any component of CNTO 95.
- •5. Clinically important active infection.
- •6. Known human immunodeficiency virus (HIV) positivity.
- •7. Presence of nonmeasurable lesions only (ie, bone metastases or malignant effusions).
- •8. CNS metastases (except for metastases that have been stable for at least 6 months after resection or irradiation).
- •9. Prior radiation to target lesions (palliative radiation therapy to nontarget lesions is permitted).
- •10. 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.
- •11. Concurrent immunotherapy, biotherapy, radiotherapy, chemotherapy, or investigational therapy.
- •12. Requires concurrent therapeutic use of anticoagulation (except for low-dose prophylactic warfarin, anti-platelet agents, or low-molecular-weight heparin).
- •13. History of bleeding diathesis.
- •14. Recurrent deep vein thrombosis (DVT) or DVT within the 6 months preceding treatment assignment/randomization.
- •15. Planned surgery (except for minor surgical procedures) during study period.
- •16. History of uveitis.
- •17. Any medical condition that, in the opinion of the investigator, may compromise the compliance of the subject to receive study treatment.
- •18. Requires hematopoietic growth factors or transfusion of blood products to meet eligibility criteria.
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