临床试验/NCT00254579

NCT00254579已完成2 期

A Phase 2, Open Label, Single Arm Study To Evaluate The Efficacy, Safety, Tolerability And Pharmacokinetics Of CP-675,206 In Patients With Advanced Refractory And/Or Relapsed Melanoma

AstraZeneca2 个研究点分布在 2 个国家目标入组 251 人开始时间: 2005年12月最近更新: 2012年6月7日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: AstraZeneca
入组人数: 251
试验地点: 2
主要终点: To assess the anti-tumor efficacy, as determined by objective response rate, of intravenous CP-675,206 administered at a dose of 15 mg/kg every 90 days to patients with relapsed or refractory advanced melanoma

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

CP-675,206 is a fully human monoclonal antibody (mAb). It binds to the CTLA4 molecule, which is expressed on the surface of activated T lymphocytes. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 is not expected to have a direct effect on tumor cells. CP-675,206 been shown to induce durable tumor responses in patients with metastatic melanoma in Phase 1 and Phase 2 clinical studies.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Surgically incurable Stage III or IV melanoma
•One prior systemic treatment for metastatic melanoma
•Measurable disease
•Eastern Cooperative Oncology Group (ECOG) PS = 0 or 1

排除标准

•Melanoma of ocular origin
•Received prior vaccine
•Received prior CTLA4-inhibiting agent
•History of, or significant risk for, chronic inflammatory or autoimmune disease
•Potential requirement for systemic corticosteroids

研究组 & 干预措施

15 mg/kg CP-675,206

Experimental

干预措施: CP-675,206 (Drug)

结局指标

主要结局

To assess the anti-tumor efficacy, as determined by objective response rate, of intravenous CP-675,206 administered at a dose of 15 mg/kg every 90 days to patients with relapsed or refractory advanced melanoma

时间窗: Tumor response is assessed every 2-3 months until disease progression

次要结局

Survival(At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug)
Safety(At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug)
Pharmaco Kinetic(At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug)
Health-related QoL(At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug)

研究者

发起方

AstraZeneca

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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