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: 14.0Level: LLTClassification code 10002646Term: AnorexiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.0Level: LLTClassification code 10064015Term: Cancer cachexiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-023648-34-CZ
• Lead Sponsor: Helsinn Therapeutics (U.S.), Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-08
• Last Update Posted: 19 October 2015

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 (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 <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
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified