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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00866970
Other study ID # ALD518-CLIN-004
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2008
Est. completion date December 2009

Study information

Verified date September 2017
Source CSL Behring
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to asses the safety and efficacy of ALD518 in patients with Non-Small Cell Lung Cancer-Related Fatigue and cachexia (weight-loss).


Description:

This is a phase II, double-blind, randomized, placebo-controlled study of ALD518 in patients with NSCLC related fatigue and cachexia.

It is estimated that a total of 120 patients will be randomized to ALD518 80 mg, 160 mg, 320 mg, or placebo in a 1:1:1:1 ratio.

A total of eight visits (excluding the Screening visit) will take place over a period of 24 weeks: Day 1, Weeks 2, 4, 8, 12, 16, 20, and 24.

Enrolled patients will be screened within a 4 week period (Day 35 to 7). Randomization to treatment will be within a 12 day period (Day 14 to 3), before initial dosing on Day 1.

Patients will receive treatment eight weeks apart (on Day 1, and Weeks 8 and 16). All patients will remain at the clinic for at least 4 hours from the time the infusion is started. Follow-up visits will occur four and eight weeks after the last dose of study drug, at Weeks 20 and 24, respectively.


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date December 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Confirmed diagnosis of NSCLC incurable by other treatments including surgery

- A =5 % loss of body weight in the preceding 3 months

- A C-reactive protein (CRP) concentration = 10 mg/L

- Life Expectancy of at least 12 weeks

Exclusion Criteria:

- Treatment with chemotherapy, large-field radiotherapy, or surgery for treatment of cancer in the past 30 days

- AST/ALT = 3 x ULN at screening

- Hemoglobin < 8 g/dL at Screening

- History of or active diagnosis of Tuberculosis

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
ALD518
ALD518 80 mg on Day 1, Week 8 and Week 16
ALD518
ALD518 160 mg IV on Day 1, Week 8 and Week 16
ALD518
ALD518 360 mg IV on Day 1, Week 8, and Week 16
Infusion of 0.9% Saline without ALD518
Infusion of 0.9% Saline without addition of ALD518

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Rivercity Hospital Research Centre Auchenflower Queensland
Australia Australian Clinical Research Organisation Kippa Ring Queensland
Australia Palliative Care Launceston General Hospital Launceston Tasmania
Canada Cross Cancer Institute Edmonton Alberta
Canada McGill University, Department of Oncology Montreal Quebec
Canada Atlantic Health Sciences Corporation Saint John New Brunswick
Georgia A. Gvamichava National Cancer Centre Tbilisi
Georgia Medulla Chemotherapy and Immunotherapy Clinic Tbilisi
Georgia Union Cancer Prevention Centre Tbilisi
India Kidwai Memorial Institute of Oncology Bangalore
India Kailash Cancer Hospital and Research Centre Gujarat
India IndoAmerican Cancer Institute & Research Center Hyderabad
India SEAROC Cancer Centre Jaipur
India Orchid Nursing Home Kolkata
India Shatabdi Hospital Mumbai
India Tata Memorial Hospital Mumbai
India Curie Manavata Cancer Centre Nasik Maharashtra
India Dr. Kamakshi Memorial Hospital Pallikaranai Chennai
India GKNM Hospital Pappanaickenpalayam Coimbatore
India Indira Gandhi Institute of Medical Sciences Patna Bihar
India Mahavir Cancer Sansthan Patna
India Jehangir Clinical Development Centre Pvt. Ltd. Pune
New Zealand P3 Research LTD Tauranga
Poland Oddzial Chorob Pluc i Leczenia Raka Pluc Bydgoszcz
Poland Oddzial Chemioterapii Szpital Morski Gdynia
Poland II Oddzia Chorob Pluc z Pododdzialem Chemioterapii Krakow
Poland Oddzial II Chemioterapii Specjalistyczny Szpital Szczecin
Romania Professor Dr. Al Trestioreanu Institute Bucharest
Romania Professor Dr. I Chiricuta Institute of Oncology and Radiotherapy Cluj-Napoca
Romania Oradea Clinical County Hospital Medical Oncology Department Oradea
Romania County Hospital Sibiu Medical Oncology Department Sibiu
Russian Federation Territorial Clinical Oncology Dispensary Krasnodar Krasnodar Territory
Russian Federation City Clinical Hospital No. 1 Novosibirsk
Russian Federation Stavropol Territorial Clinical Pyatigorsk Stavropol Territory
Russian Federation Saint-Petersburg State Medical University, I.P. Pavlov Saint-Petersburg
Russian Federation St. Petersburg City Oncology Dispensary Saint-Petersburg
Russian Federation Republic Oncology Dispensary Ufa Republic Of Bashkortostan
Russian Federation Yaroslavl Regional clinical Oncology Hospital Yaroslavl
Serbia Clinical Hospital Center Bezanijska Kosa Belgrade
Serbia Institute of Lung Diseases and TB Belgrade
Serbia Clinical Centre Kragujevac Kragujevac
Serbia Institute for Pulmonary diseases of Vojvodina Sremska

Sponsors (1)

Lead Sponsor Collaborator
CSL Behring

Countries where clinical trial is conducted

Australia,  Canada,  Georgia,  India,  New Zealand,  Poland,  Romania,  Russian Federation,  Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Safety parameters. 20 weeks
Secondary Time to symptomatic progressions at Weeks 12 and 24 24 weeks
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