The purpose of this study is to evaluate doses of anamorelin for safety and efficacy in patients with non-small cell lung cancer.
Cancer cachexia is a devastating, often late-stage complication of an underlying malignancy. Despite the significant importance of cancer-related cachexia, treatments are lacking and there are no products approved for this indication. Anamorelin HCl, by virtue of its ghrelin agonist activity, may serve a role in the treatment of cancer cachexia. This placebo controlled dose range study will evaluate the safety and efficacy of anamorelin HCl in patients with non-small cell lung cancer, a cancer associated with a high prevalence of cachexia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
228
Hand grip strength and body weight
Time frame: Twelve weeks
Quality of Life and Biomarker
Time frame: Twelve weeks
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Osler Medical
Melbourne, Florida, United States
Augusta Oncology Associates
Augusta, Georgia, United States
South Georgia Medical Center
Valdosta, Georgia, United States
Investigative Clinical Research of Indiana
Indianapolis, Indiana, United States
John Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Center
Boston, Massachusetts, United States
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
...and 23 more locations