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Brief Title: Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Anamorelin HCl Dose Range Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC
Study ID: NCT00622193
Brief Summary: The purpose of this study is to evaluate doses of anamorelin for safety and efficacy in patients with non-small cell lung cancer.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
The West Clinic, Corinth, Mississippi, United States
The West Clinic, Southaven, Mississippi, United States
Washington University School of Medicine, St Louis, Missouri, United States
Duke University Medical Center, Durham, North Carolina, United States
South Carolina Cancer Specialists, Hilton Head Island, South Carolina, United States
The West Clinic, Memphis, Tennessee, United States
Baylor College of Medicine/VAMC, Houston, Texas, United States
The Methodist Hospital Research Institute, Houston, Texas, United States
North West Medical Specialties, PLLC, Puyallup, Washington, United States
Regional Cancer Centre Indira Gandhi Institute of Medical Sciences, Patna, Bihar, India
Cancer Clinic 208, Nagpur, Maharashtra, India
Noble Hospital, Pune, Maharashtra, India
Ruby Hall Clinic, Pune, Maharashtra, India
Kaushalya Medical Foundation Trust Hospital, Thane, Maharashtra, India
SEAROC Cancer Center, Jaipur, Rajasthan, India
Jawaharlal Nehru Cancer Hospital and Research Centre, Bhopal, , India
Kamakshi Memorial Hospital, Chennai, , India
Dharamshila Cancer Hospital and Research Center, Delhi, , India
Bhagwan Mahaveer Cancer Hospital and Resaerch Center, Jaipur, , India
Birla Cancer Centre SMS Medical College Hospital, Jaipur, , India
Kodlikeri Memorial Hospital, Maharashtra, , India
Shatabdi Super Speciality Hospital, Mumbai Naka, Nasik, , India
Jaslok Hospital and Research Centre, Mumbai, , India
Name: Jennifer Temel, MD
Affiliation: Massachusetts General Hospital
Role: STUDY_DIRECTOR