EUCTR2009-012820-97-GB进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients with Locally Advanced or Metastatic Adrenocortical Carcinoma - GALACCTIC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
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
- •Histologically confirmed adrenocortical carcinoma;
- •Measurable disease according to RECIST (version 1.1);
- •ECOG PS <= 2;
- •Fasting glucose – Concurrent use of non-insulinotropic oral antihyperglycemic therapy is permitted if the dose has been stable for >/= 4 weeks at the time of randomization.
- •At least 1 but no more than 2 prior drug regimens for locally advanced/metastatic ACC. A minimum of 3 weeks must have elapsed between the end of prior treatment and randomization:
- •– All patients must have received prior mitotane, either as neoadjuvant, adjuvant, or locally advanced/metastatic therapy.
- •– Adjuvant and neoadjuvant mitotane will not be counted as prior drug regimens or systemic cytotoxic chemotherapy.
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •Type 1 diabetes mellitus or Type 2 diabetes mellitus currently requiring insulinotropic or insulin therapy;
- •Prior IGF-1R inhibitor therapy;
- •History of significant cardiovascular disease unless the disease is well controlled. Significant disease includes second/third degree heart block; clinically significant ischemic heart disease; QTcF interval > 450 msec at screening; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA) Class II or worse; and/or
- •Use of drugs that have a risk of causing QT interval prolongation within 14 days prior to Day 1 dosing.
研究者
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