NCT00257205已完成3 期
A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 655
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 melanoma, either Stage IV or IIIC with N3 status for regional lymph nodes and in-transit or satellite lesions.
- •Serum lactic acid dehydrogenase (LDH) <= 2 x ULN
- •ECOG performance status of 0 or 1
排除标准
- •Received any systemic therapy for metastatic melanoma except post-surgical adjuvant treatment with cytokines (eg, alpha-interferon or GM-CSF) or with vaccines after complete resection of melanoma.
- •History of brain metastases
研究组 & 干预措施
A
Experimental
干预措施: CP-675,206 (Drug)
B
Active Comparator
Choice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice)
干预措施: dacarbazine (Drug)
B
Active Comparator
Choice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice)
干预措施: temozolomide (Drug)
结局指标
主要结局
overall survival
时间窗: August 2010
次要结局
- adverse events(1 year)
- PFS at 6 months(6 months)
- objective tumor response(1 year)
- Durable response(6 months)
- pharmacokinetics endpoints(15 months)
- pharmacogenomic endpoints(1 year)
- HQol(1 year)
- healthcare resource utilization and loss of productivity(1 year)
- human antihuman antibody response for patients in Arm A(15 months)
研究者
研究点 (1)
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