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)

Helsinn Therapeutics (U.S.), Inc0 个研究点目标入组 1 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

Trial is onging in other countries

•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

•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

发起方