A 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)

PHASE3CompletedINTERVENTIONAL
Enrollment

318

Participants

Timeline

Start Date

May 6, 2019

Primary Completion Date

December 27, 2022

Study Completion Date

December 27, 2022

Conditions
Cachexia; CancerNon Small Cell Lung Cancer
Interventions
DRUG

anamorelin HCl

100 mg anamorelin HCl (administered as 100 mg tablets in the fasted condition)

DRUG

Placebo Oral Tablet

Placebo (administered as matching placebo tablets in the fasted condition)

Trial Locations (65)

1000

Jules Bordet Institut, Brussels

1200

Saint Luc University Hospital, Brussels

2650

University Hospital Antwerp (UZA), Edegem

3039

"Medical Center VERUM Limited Liability Company", Kyiv

3050

The Royal Melbourne Hospital, Parkville

3065

St Vincent's Hospital Melbourne, Fitzroy

3215

Barwon Health, The McKellar Centre, North Geelong

4215

Gold Coast University Hospital, Southport

5042

Flinders Medical Centre, Bedford Park

5112

Calvary Central Districts Hospital, Elizabeth Vale

6000

Charleroi Grand Hospital (GHDC), Charleroi

8800

General Hospital Delta, Roeselare

10000

University Hospital Center Zagreb, Zagreb

10960

Hematology Oncology Center at Nyack Hospital, Nyack

14642

University of Rochester, Medical Center, Rochester

21000

University Hospital Center Split, Split

27710

Duke Cancer Center, Durham

33881

Bond & Steele Clinic P.A., Winter Haven

36011

"Public Entreprise Poltava Regional Clinical Oncology Center under Poltava Regional Council", Poltava

43623

Toledo Clinic Cancer Center-Toledo, Toledo

46023

Public Non-Profit Enterprise 'Ternopil Regional Clinical Oncology Center'' under Temopil Regional Council, Ternopil

49055

"Medical Center MEDICAL PLAZA of the Limited Liability Company EKODNIPRO", Dnipro

49503

Cancer and Hematology Centers of Western Michigan, Grand Rapids

51101

Siouxland Regional Cancer Center dba June E.Nylen Cancer Center, Sioux City

60077

Presence Infusion Care, Skokie

61070

"Communal Non-Profit Enterprise Regional Center of Oncology", Kharkiv

61166

Publ Non- Profit Ent. under Kharkiv Reg. Council, Kharkiv

67214

Cancer Center of Kansas, Wichita

69059

"Medical Center of Limited Liability Company ONCOLIFE", Zaporizhzhya

85719

The University of Arizona Cancer Center - North Campus, Tucson

92708

Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc., Fountain Valley

92801

Pacific Cancer Medical Center, Inc, Anaheim

93309

CBCC Global Research Inc, Bakersfield

94904

Marin Cancer Care, Greenbrae

196247

Oncology Center of Moskovskiy District, Saint Petersburg

197082

AV Medical Group, Saint Petersburg

197183

Palliative Care Center Devita, Saint Petersburg

198255

City Clinical Oncology Center, Saint Petersburg

200347

"Sf. Nectarie Oncology Center, Medical Oncology Department", Craiova

300239

S.C. Oncomed SRL, Medical Oncology Department, Timișoara

354057

Oncology Center #2, Sochi

357502

Pyatigorsk Interdistric Oncology Center, Pyatigorsk

400015

"Prof. Dr. Ion Chiricuta Institute of Oncology, Medical Oncology Department", Cluj-Napoca

400138

Volgograd Regional Clinical Oncology Center, Volgograd

420029

Republican Clinical Oncology Center, Kazan'

430032

Ogaryov Mordovia National Research State University, Republican Oncology Center, Saransk

430291

SC Oncopremium Team SRL, Medical Oncology Department, Baia Mare

443031

Samara Regional Clinical Oncology Center, Samara

540156

Topmed Medical Center, Medical Oncology Department, Târgu Mureş

720237

Sf. Ioan cel Nou Country Emergency Hospital, Oncology Department, Suceava

06708

Smilow Cancer Hospital at Yale-New Haven, Waterbury

03756

Dartmouth-Hitchcock Medical Center, Lebanon

08724

New Jersey Hematology Oncology Associates Inc, Brick

08822

Hunterdon Hematology Oncology LLC, Flemington

77030-4009

The University of Texas MD Anderson Cancer Center, Houston

52 100

General Hospital Pula, Pula

86-300

Wladyslaw Bieganski Regional Specialist Hospital, Clinical Oncology Department, Grudziądz

40-060

"VEGAMED Non-Public Healthcare Facility", Katowice

90-302

MSF Institute Ltd. Santa Familia Medical Institute, Lodz

60-693

MED - POLONIA Ltd., Poznan

82-550

Specialist Hospital in Prabuty sp. z o.o. [limited liability company], Department of Pulmonology, Prabuty

02-781

Maria Skfodowska-Curie Institute of Oncology, Department of Lung and Thoracic Cancers, Warsaw

05-135

Mazovian Oncology Hospital, Oncology Outpatient Clinic, Wieliszew

022328

Alexandru Trestioreanu Institute of Oncology, Bucharest

03037

"Private Enterprise First Private Clinic", Kyiv

Sponsors
All Listed Sponsors
lead

Helsinn Healthcare SA

INDUSTRY