Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study
This is a randomized, double-blind, parallel-group, placebo-controlled, extension study to
assess the safety and efficacy of Anamorelin HCl in NSCLC-C patients.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Evaluate the safety and tolerability of Anamorelin
Incidence of adverse events (assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 [NCI CTCAE Version 4]) and Vital signs, electrocardiogram (ECG), and safety laboratory assessments will be assessed.
12 weeks
Yes
United States: Food and Drug Administration
HT-ANAM-303
NCT01395914
July 2011
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Philadelphia, Pennsylvania 19104 | |
Louisville, Kentucky 40207 | |
McLean, Virginia 22101 | |
Boston, Massachusetts | |
Charlotte, North Carolina | |
Indianapolis, Indiana | |
Charleston, South Carolina | |
Washington, District of Columbia |