EUCTR2010-023650-36-PL进行中（未招募）不适用
Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer – Cachexia (NSCLC-C): An Extension Study(ROMANA-3)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 350
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
- 性别
- All
入选标准
- •The patient has completed the Day 85 Visit in the original trial (Study HT ANAM-301 or HT-ANAM-302) and the Investigator considers the patient to be appropriate to continue to receive an additional 12 weeks of study drug administration. The patient must start dosing on the extension study within 5 days of completing dosing on the original trial.
- •Females and males at least 18 years of age
- •ECOG performance status less than / equal to 2
- •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 234
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 116
排除标准
- •Women who are pregnant or breast-feeding
- •Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to enrollment into the extension study. Patients must be well recovered from acute effects of surgery prior to screening. Patients should not have plans to undergo major surgical procedures during the treatment period.
- •Patients unable to readily swallow oral tablets. Patients with severe gastointestinal disease (including esophagitis, gastritis, malaborption, or obstructive symptoms) or intractable or frequent vomiting are excluded.
- •Has known or symptomatic brain metastases
研究者
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