Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)

PHASE3CompletedINTERVENTIONAL
Enrollment

484

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

January 31, 2014

Study Completion Date

February 28, 2015

Conditions
CachexiaNon-Small Cell Lung Cancer
Interventions
DRUG

Anamorelin HCl

Anamorelin HCl will be orally administered daily at least one hour before meal

DRUG

Placebo

Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before meal

Trial Locations (60)

Unknown

Fullerton

Glendale

La Jolla

Riverside

Orange City

Quincy

Indianapolis

Louisville

Boston

Northport

Cincinnati

Houston

Brest

Lesnoy

Minsk

Antwerp

Brussels

Genk

Liège

Edmonton

Sault Ste. Marie

Toronto

Montreal

Benešov

Brno

Hlučín

Liberec

Nymburk

Lyon

Villejuif

Berlin

Großhansdorf

Halle

Minden

Budapest

Placenza

Rozzano

Amsterdam

Goes

Maastricht

Nieuwegein

Grudziądz

Katowice

Krakow

Lublin

Saint Petersburg

Yekaterinburg

Belgrade

Kamenitz

Golnik

Ljubljana

Barcelona

Córdoba

Seville

Valencia

Dnipropetrovsk

Donetsk

Kharkiv

Kyiv

Zaporizhzhya

All Listed Sponsors
lead

Helsinn Therapeutics (U.S.), Inc

INDUSTRY

NCT01387269 - Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1) | Biotech Hunter | Biotech Hunter