Non-Small Cell Lung Cancer related Cachexia (NSCLC-C) MedDRA version: 13.1 Level: LLT Classification code 10002646 Term: Anorexia System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 13.1 Level: LLT Classification code 10064015 Term: Cancer cachexia System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Helsinn Therapeutics (U.S.), Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Females and males at least 18 years of age •Documented histologic or cytologic diagnosis of AJCC Stage III or IV NSCLC. Stage III patients must have unresectable disease. •With regard to chemotherapy and/or radiation therapy: Patients may be receiving maintenance chemotherapy (after first line chemotherapy), Patients may be initiating a new chemotherapy (first or second line) and/or radiation therapy regimen within 7 days of study drug randomization, patients are receiving no chemotherapy and/or radiation for NSCLC •Involuntary weight loss of greater than/equal to 5% body weight within 6 months prior to screening or a screening BMI =65 years) yes F.1.3.1 Number of subjects for this age range 160
Exclusion criteria
Exclusion criteria: •Other forms of lung cancer (eg, small cell, mesothelioma) •Women who are pregnant or breast-feeding •Patients who have completed 2 or more prior cytotoxic chemotherapy regimens •Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization. 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 gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded •Has untreated clinically relevant hypothyroidism •Has known or symptomatic brain metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the effect of Anamorelin HCl on lean body mass (LBM) as measured by dual energy X-ray absorptiometry (DXA) 2. To evaluate the effect of Anamorelin HCl on muscle strength as measured by handgrip strength (HGS) ;Secondary Objective: 1. To evaluate the effect of Anamorelin HCl on body weight 2. 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) 3. To evaluate the effect of Anamorelin HCl on overall survival ;Primary end point(s): 1. Lean Body Mass change from baseline as measured by DXA 2. Hand Grip Strength of the non-dominant hand change from baseline;Timepoint(s) of evaluation of this end point: 1. Lean Body Mass change from baseline as measured by DXA over 12 weeks 2. Hand Grip Strength of the non-dominant hand change over 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage change in Lean Body Mass 2. Percentage change on Hand Grip Strength of the non-dominant hand 3. Changes in body weight 4. Change in Hand Grip Strength of the dominant hand 5. Quality of life 6. Overall survival ;Timepoint(s) of evaluation of this end point: 1. Percentage change in Lean Body mass over 12 weeks 2. Percentage change on Hand Grip Strength of the non-dominant hand over 12 weeks 3. Changes in body weight at Weeks 3, 6, 9, 12 4. Change in Hand Grip strength of the dominant hand at Weeks 6, 12 5. Quality of life as assessed by FAACT and FACIT-F at Weeks 3, 6, 9, 12 6. Overall survival assessed until death up to 1 year | — |
Countries
Australia, Hungary, Israel, Poland, Russian Federation, United Kingdom, United States
Contacts
Public ContactMedpace Regulatory Submissions
Medpace , Inc
Outcome results
None listed