Spots Global Cancer Trial Database for Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)
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Trial Identification
Brief Title: Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)
Official Title: Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C
Study ID: NCT01387269
Study Description
Brief Summary: The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.
Detailed Description: This is a randomized, double-blind, placebo-controlled, multicenter study to assess the safety and efficacy of Anamorelin in patients with non-small cell lung cancer-cachexia (NSCLC-C). The primary efficacy analysis will include the treatment difference in the change in lean body mass and physical function. Pharmacokinetic (PK) samples will also be collected at Day 43 visit for population PK.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Fullerton, California, United States
, Glendale, California, United States
, La Jolla, California, United States
, Riverside, California, United States
, Orange City, Florida, United States
, Quincy, Illinois, United States
, Indianapolis, Indiana, United States
, Louisville, Kentucky, United States
, Boston, Massachusetts, United States
, Northport, New York, United States
, Cincinnati, Ohio, United States
, Houston, Texas, United States
, Brest, , Belarus
, Lesnoy, , Belarus
, Minsk, , Belarus
, Antwerpen, , Belgium
, Brussels, , Belgium
, Genk, , Belgium
, Liege, , Belgium
, Edmonton, Alberta, Canada
, Sault Ste. Marie, Ontario, Canada
, Toronto, Ontario, Canada
, Montreal, Quebec, Canada
, Benesov, , Czechia
, Brno, , Czechia
, Hlucin, , Czechia
, Liberec, , Czechia
, Nymburk, , Czechia
, Lyon Cedex, , France
, Villejuif cedex, , France
, Berlin, , Germany
, Grosshansdorf, , Germany
, Halle, , Germany
, Minden, , Germany
, Budapest, , Hungary
, Placenza, , Italy
, Rozzano, , Italy
, Amsterdam, , Netherlands
, Goes, , Netherlands
, Maastricht, , Netherlands
, Nieuwegein, , Netherlands
, Grudziadz, , Poland
, Katowice, , Poland
, Krakow, , Poland
, Lublin, , Poland
, Ekaterinburg, , Russian Federation
, St. Petersburg, , Russian Federation
, Belgrade, , Serbia
, Sremska Kamenica, , Serbia
, Golnik, , Slovenia
, Ljubljana, , Slovenia
, Barcelona, , Spain
, Cordoba, , Spain
, Sevilla, , Spain
, Valencia, , Spain
, Dnipropetrovsk, , Ukraine
, Donetsk, , Ukraine
, Kharkiv, , Ukraine
, Kyiv, , Ukraine
, Zaporizhzhya, , Ukraine
Contact Details
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