Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2)

PHASE3CompletedINTERVENTIONAL
Enrollment

495

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

November 30, 2013

Study Completion Date

February 28, 2015

Conditions
CachexiaNon-Small Cell Lung Cancer
Interventions
DRUG

Anamorelin HCl

Anamorelin HCL 100 mg will be orally administered daily at least 1 hour prior to meal

DRUG

Placebo

Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour prior to meal before the first meal of the day.

Trial Locations (46)

Unknown

Corona

Fountain Valley

Glendale

Washington D.C.

Baltimore

Detroit

Lake Success

Durham

Cincinnati

Cleveland

Sylvania

West Reading

Charleston

Falls Church

Prairiewood

East Bentleigh

Parkville

Adelaide

Budapest

Nyíregyháza

Székesfehérvár

Szikszó

Törökbálint

Beersheba

Haifa

Jerusalem

Kfar Saba

Petach Tikvah

Tel Aviv

Tel Litwinsky

Ẕerifin

Bydgoszcz

Grudziądz

Katowice

Krakow

Lodz

Lublin

Szczecin

Warsaw

Krasnodar

Moscow

Novosibirsk

Saint Petersburg

Yekaterinburg

Leicester

Middlesex

All Listed Sponsors
lead

Helsinn Therapeutics (U.S.), Inc

INDUSTRY

NCT01387282 - Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2) | Biotech Hunter | Biotech Hunter