A clinical trial studying the safety and effectiveness of the study drug Anamorelin HCl for treating cachexia (weight loss and muscle mass loss) in patients with Non-Small Cell Lung Cancer

Conditions: on-Small Cell Lung Cancer related Cachexia (NSCLC-C)
MedDRA version: 14.1Level: LLTClassification code 10064015Term: Cancer cachexiaSystem Organ Class: 100000004861
Therapeutic area: Diseases [C] - Cancer [C04]
MedDRA version: 14.1Level: LLTClassification code 10002646Term: AnorexiaSystem Organ Class: 100000004861

Registration Number: EUCTR2010-023648-34-HU

Lead Sponsor: Helsinn Therapeutics (U.S.), Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 477

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; Patients planning to initiate a new chemotherapy and/or radiation therapy regimen may do so only within ± 14 days of randomization; Patients may have completed a chemotherapy and/or radiation therapy and/or have no plan to initiate a new regimen within 12 weeks from randomization. At least 14 days must elapse from the completion of the chemotherapy and/or radiation therapy prior to randomization.
•Involuntary weight loss of greater than/equal to 5% body weight within 6 months prior to screening or a screening BMI <20 kg/m2.
•Body mass index less than/equal to 30 kg/m2
•ECOG 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 317
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

Exclusion Criteria

•Other forms of lung cancer (eg, small cell, mesothelioma)
•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 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. To evaluate the effect of Anamorelin HCl on lean body mass (LBM) as measured by dual energy X-ray absorptiometry (DXA)<br>2. To evaluate the effect of Anamorelin HCl on muscle strength as measured by handgrip strength (HGS) <br>;Secondary Objective: 1. To evaluate the effect of Anamorelin HCl on body weight<br>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)<br>3. To evaluate the effect of Anamorelin HCl on overall survival<br>;Primary end point(s): 1. Lean Body Mass change from baseline as measured by DXA <br>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<br>2. Hand Grip Strength of the non-dominant hand change over 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Percentage change in Lean Body Mass<br>2. Percentage change on Hand Grip Strength of the non-dominant hand<br>3. Changes in body weight<br>4. Change in Hand Grip Strength of the dominant hand <br>5. Quality of life<br>6. Overall survival<br>;Timepoint(s) of evaluation of this end point: 1. Percentage change in Lean Body mass over 12 weeks<br>2. Percentage change on Hand Grip Strength of the non-dominant hand over 12 weeks<br>3. Changes in body weight at Weeks 3, 6, 9, 12<br>4. Change in Hand Grip strength of the dominant hand at Weeks 6, 12<br>5. Quality of life as assessed by FAACT and FACIT-F at Weeks 3, 6, 9, 12<br>6. Overall survival assessed until death up to 1 year<br>

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