A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in adult patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
INDICATION: Treatment of malignancy associated weight loss or anorexia in patients with NSCLC.
STUDY DRUG: Anamorelin HCl administered orally.
The treatment of lung cancer is not enough. If you only treat a disease, the disease wins. Treating patients is what we here at GCC are all about. This means that not only must we bring the best and most advanced lung cancer treatments here to Gettysburg, but we also need to consider what else cancer is doing to our patients. Our efforts to find the best “Supportive Care” treatments has led us to this clinical study.
Weight loss and anorexia are among the symptoms of a syndrome caused by lung cancer called cachexia. This syndrome leads to a reduced food intake that can be compounded by secondary nutrition impact symptoms. The physical symptoms of poor nutrition are also associated with a lower quality of life, higher stress levels and more severe symptoms. These symptoms include changes in food taste, fatigue, decrease in appetite and early satiety. These symptoms can cause cancer treatments to be reduced or held which contributes to poorer survival status.
The treatment of weight loss and anorexia caused by lung cancer is considered an area of unmet medical need. Simply stated, we do not have adequate treatments for this. To that end we are participating in this study.
Anamorelin HCl is an orally-active selective ghrelin receptor agonist, formerly known as the growth hormone [GH] secretagogue receptor, GHS-R. Ghrelin or longer-acting ghrelin mimetics have been shown to possess anabolic, appetite-enhancing, adiposity-increasing, and anti-inflammatory properties.
Anamorelin has been studied extensively on phase 1 and 2 studies. Results demonstrate that patients experienced an increase in lean body mass, body weight and improvement in anorexia/cachexia symptoms. Safety results show that anamorelin is well tolerated.
The primary purpose of this study is to further evaluate the impact of anamorelin HCl on body weight and anorexia symptoms in patients with advanced non-small cell cancer (NSCLC).
If you are interested in more information on this study, please contact us. Refer to the Helsinn ANAM-17-20 Study. You can also find information on this study by going to clinicaltrials.gov website and searching for NCT03743051.