NL-OMON38190
已完成
3 期
Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer - Cachexia (NSCLC-C): An Extension Study;(ROMANA-3) - Helsinn HT-ANAM-303 extension study (ROMANA 3)
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- cachexie
- 发起方
- Helsinn Therapeutics (U.S.), Inc
- 入组人数
- 1
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
Trial is onging in other countries
研究者
入排标准
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
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
结局指标
主要结局
未指定
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