NCT00618319已完成2 期
An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST) Refractory to, Intolerant of, or Not a Candidate for Imatinib and Sunitinib Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes in FDG-PET imaging
研究概览
简要总结
This study will examine the effect of BIIB021 on GIST growth and metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- •Age greater than or equal to 18 years at the time of informed consent.
- •Pathologically confirmed GIST refractory to, intolerant of, or not a candidate for imatinib and sunitinib therapy.
- •FDG PET standard uptake value (SUVmax; averaged over a maximum of 5 lesions) greater than or equal to 2 at screening.
- •ECOG performance status of less than or equal to
- •Lab values consistent with adequate renal hepatic and bone marrow function.
- •Must utilize effective contraception.
排除标准
- •Prior treatment with imatinib, sunitinib, or sorafenib with in 14 days of day
- •Prior treatment with Hsp90 inhibitors at any time.
- •Prior antitumor therapies including prior experimental agents, approved antitumor small molecules (excluding imatinib, sunitinib, or sorafenib) and biologics, or radiotherapy with in 28 days or <3 half lives (whichever is longer) before start of BIIB021treatment.
- •Diabetes treated with insulin and/ or concurrent severe or uncontrolled other medical disease (i.e, systemic infection, hypertension, coronary artery disease, congestive heart failure).
- •History of/ or predisposition to seizures.
研究组 & 干预措施
1
Experimental
BIIB021
干预措施: BIIB021 (Drug)
结局指标
主要结局
Changes in FDG-PET imaging
时间窗: 28 days
次要结局
- Characterize the safety profile of BIIB021(Duration of study)
研究者
研究点 (2)
Loading locations...
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