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

Fatigue Clinical Trial

Official title:

A Phase II Study to Determine the Safety, Efficacy, and Pharmacokinetics of Multiple Intravenous Doses of ALD518 80 mg, 160 mg, and 320 mg Versus Placebo Administered to Patients With Non-Small Cell Lung Cancer-Related Fatigue and Cachexia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00866970
• Other study ID #: ALD518-CLIN-004
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Cachexia
• Fatigue
• Lung Neoplasms
• NSCLC

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