Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia

PHASE2CompletedINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

August 31, 2009

Study Completion Date

December 31, 2009

Conditions
NSCLCFatigueCachexia
Interventions
BIOLOGICAL

ALD518

ALD518 80 mg on Day 1, Week 8 and Week 16

BIOLOGICAL

ALD518

ALD518 160 mg IV on Day 1, Week 8 and Week 16

BIOLOGICAL

ALD518

ALD518 360 mg IV on Day 1, Week 8, and Week 16

BIOLOGICAL

Infusion of 0.9% Saline without ALD518

Infusion of 0.9% Saline without addition of ALD518

Trial Locations (43)

4021

Australian Clinical Research Organisation, Kippa-Ring

4066

Rivercity Hospital Research Centre, Auchenflower

5000

Royal Adelaide Hospital, Adelaide

7250

Palliative Care Launceston General Hospital, Launceston

11080

Clinical Hospital Center Bezanijska Kosa, Belgrade

34000

Clinical Centre Kragujevac, Kragujevac

150054

Yaroslavl Regional clinical Oncology Hospital, Yaroslavl

197022

Saint-Petersburg State Medical University, I.P. Pavlov, Saint Petersburg

198255

St. Petersburg City Oncology Dispensary, Saint Petersburg

302013

SEAROC Cancer Centre, Jaipur

350040

Territorial Clinical Oncology Dispensary, Krasnodar

357500

Stavropol Territorial Clinical, Pyatigorsk

391760

Kailash Cancer Hospital and Research Centre, Gujarat

400015

Professor Dr. I Chiricuta Institute of Oncology and Radiotherapy, Cluj-Napoca

410032

Oradea Clinical County Hospital Medical Oncology Department, Oradea

450054

Republic Oncology Dispensary, Ufa

500034

IndoAmerican Cancer Institute & Research Center, Hyderabad

550245

County Hospital Sibiu Medical Oncology Department, Sibiu

560029

Kidwai Memorial Institute of Oncology, Bangalore

600100

Dr. Kamakshi Memorial Hospital, Pallikaranai

630047

City Clinical Hospital No. 1, Novosibirsk

641037

GKNM Hospital, Pappanaickenpalayam

801505

Mahavir Cancer Sansthan, Patna

T6G 1Z2

Cross Cancer Institute, Edmonton

E2l 4L2

Atlantic Health Sciences Corporation, Saint John

H2W 1S6

McGill University, Department of Oncology, Montreal

0177

A. Gvamichava National Cancer Centre, Tbilisi

Union Cancer Prevention Centre, Tbilisi

0186

Medulla Chemotherapy and Immunotherapy Clinic, Tbilisi

Unknown

Indira Gandhi Institute of Medical Sciences, Patna

Shatabdi Hospital, Mumbai

422 304

Curie Manavata Cancer Centre, Nashik

700 054

Orchid Nursing Home, Kolkata

400 012

Tata Memorial Hospital, Mumbai

411 001

Jehangir Clinical Development Centre Pvt. Ltd., Pune

31-40

P3 Research LTD, Tauranga

85-326

Oddzial Chorob Pluc i Leczenia Raka Pluc, Bydgoszcz

81-519

Oddzial Chemioterapii Szpital Morski, Gdynia

31-202

II Oddzia Chorob Pluc z Pododdzialem Chemioterapii, Krakow

70-891

Oddzial II Chemioterapii Specjalistyczny Szpital, Szczecin

022328

Professor Dr. Al Trestioreanu Institute, Bucharest

11 000

Institute of Lung Diseases and TB, Belgrade

21 104

Institute for Pulmonary diseases of Vojvodina, Sremska

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CSL Behring

INDUSTRY