Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer - Cachexia (NSCLC-C): An Extension Study;(ROMANA-3)
- Conditions
- cachexiewasting syndroom1000301810027656
- Registration Number
- NL-OMON38190
- Lead Sponsor
- Helsinn Therapeutics (U.S.), Inc
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the safety and tolerability of Anamorelin HCl. </p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the effect of Anamorelin HCl on body weight<br /><br>To evaluate the effect of Anamorelin HCl on muscle<br /><br>strength as measured by handgrip strength (HGS)<br /><br>To evaluate the effect of Anamorelin HCl on quality of life as assessed using<br /><br>the FAACT (Functional Assessment of Anorexia/Cachexia Treatment) and the<br /><br>FACIT-F (Functional Assessment of Chronic Illness Therapy - Fatigue)<br /><br>To evaluate the effect of Anamorelin HCl on quality of life as assessed using<br /><br>the<br /><br>Hunger Assessment Scale </p><br>