跳至主要内容
临床试验/NCT00066196
NCT00066196已完成2 期

A Phase II, Randomized, Open-Label Study Evaluating The Antitumor Activity Of MEDI-522, A Humanized Monoclonal Antibody Directed Against The Human Alpha V Beta 3 Integrin, ± Dacarbazine In Patients With Metastatic Melanoma

MedImmune LLC49 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2003年8月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
MedImmune LLC
入组人数
110
试验地点
49
主要终点
Explore antitumor activity of MEDI-522 in patients with metastatic melanoma.

研究概览

简要总结

The primary objectives of this study are:

  • To explore the antitumor activity of MEDI-522 ± DTIC in patients with metastatic melanoma.
  • To determine the safety of MEDI-522 ± DTIC in this patient population.

详细描述

This is a Phase II, randomized, open-label, two-arm, multicenter study of MEDI 522 ± DTIC in previously untreated (other than adjuvant immunotherapy) patients with Stage IV metastatic melanoma (AJCC staging).

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Explore antitumor activity of MEDI-522 in patients with metastatic melanoma.

时间窗: Screening and after every 2 cycles of treatment until disease progression. At least 4 weeks after a patient demonstrates response.

次要结局

  • Determine the safety of MEDI-522 and/or DTIC in this patient population.(Every week until disease progression, and 30 days after disease progression.)

研究者

发起方
MedImmune LLC
申办方类型
Industry

研究点 (49)

Loading locations...

相似试验