Non-Small Cell Lung Cancer related Cachexia (NSCLC-C)
Conditions
Interventions
Product Name: Anamorelin HCl
Pharmaceutical Form: Tablet
Current Sponsor code: Anamorlein HCl
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical fo
Sponsors
Helsinn Therapeutics (U.S.), Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • Women who are pregnant or breast-feeding • Patients must not be planning to initiate a new chemotherapy and/or radiation therapy regimen in the middle of the 12-week treatment period at the time of enrollment into this extension study. • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of Anamorelin HCl;Secondary Objective: 1. To evaluate the effect of Anamorelin HCl on body weight 2. To evaluate the effect of Anamorelin HCl on muscle strength as measured by hand grip strength 3. To evaluate the effect of Anamorelin HCl on quality of life as assessed using the FAACT (Functional Assessment of Anorexia/Cachexia Treatment) and the FACIT F (Functional Assessment of Chronic Illness Therapy – Fatigue) (see Appendix II) ;Primary end point(s): 1. Changes in body weight from baseline of the HT-ANAM-301 or HT-ANAM-302 trials 2. Change in Hand Grip Strength of the non-dominant hand 3. Change in HGS of the dominant hand 4. Quality of life;Timepoint(s) of evaluation of this end point: 1. Changes in body weight at Weeks 4, 8, 12 2. Changes in Hand Grip Strength of non-dominant hand at Weeks 8, 12 3. Changes in Hand Grip Strength of dominant hand at Weeks 8, 12 4. Quality of life as assessed by FAACT and FACIT-F at Weeks 4, 8, 12 | — |
Countries
Australia, Belgium, Canada, Czech Republic, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Russian Federation, Slovenia, Spain, United Kingdom, United States
Contacts
Public ContactMedpace Regulatory Submissions
Medpace, Inc
Outcome results
None listed