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

Phase 2

Completed

• Conditions: NSCLC; Fatigue; Cachexia
• Interventions: Biological: ALD518; Biological: Infusion of 0.9% Saline without ALD518

• Registration Number: NCT00866970
• Lead Sponsor: CSL Behring

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-03-20
• Study First Submitted QC: 2009-03-20
• Study First Posted: 2009-03-23
• Primary Completion: 2009-08
• Study Completion: 2009-12
• Status Verified: 2017-09
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	ALD518	ALD518
3	ALD518	ALD518
4	Infusion of 0.9% Saline without ALD518	No ALD518
1	ALD518	ALD518

Primary Outcome Measures

Name	Time	Method
Change in Safety parameters.	20 weeks

Secondary Outcome Measures

Name	Time	Method
Time to symptomatic progressions at Weeks 12 and 24	24 weeks

Trial Locations

Locations (43)

Mahavir Cancer Sansthan; 🇮🇳 Patna, India

Professor Dr. I Chiricuta Institute of Oncology and Radiotherapy; 🇷🇴 Cluj-Napoca, Romania

Territorial Clinical Oncology Dispensary; 🇷🇺 Krasnodar, Krasnodar Territory, Russian Federation

Republic Oncology Dispensary; 🇷🇺 Ufa, Republic Of Bashkortostan, Russian Federation

Stavropol Territorial Clinical; 🇷🇺 Pyatigorsk, Stavropol Territory, Russian Federation

Dr. Kamakshi Memorial Hospital; 🇮🇳 Pallikaranai, Chennai, India

Kailash Cancer Hospital and Research Centre; 🇮🇳 Gujarat, India

IndoAmerican Cancer Institute & Research Center; 🇮🇳 Hyderabad, India

Clinical Centre Kragujevac; 🇷🇸 Kragujevac, Serbia

Orchid Nursing Home; 🇮🇳 Kolkata, India

Oddzial Chorob Pluc i Leczenia Raka Pluc; 🇵🇱 Bydgoszcz, Poland

Oddzial Chemioterapii Szpital Morski; 🇵🇱 Gdynia, Poland

Oddzial II Chemioterapii Specjalistyczny Szpital; 🇵🇱 Szczecin, Poland

Saint-Petersburg State Medical University, I.P. Pavlov; 🇷🇺 Saint-Petersburg, Russian Federation

Indira Gandhi Institute of Medical Sciences; 🇮🇳 Patna, Bihar, India

Medulla Chemotherapy and Immunotherapy Clinic; 🇬🇪 Tbilisi, Georgia

City Clinical Hospital No. 1; 🇷🇺 Novosibirsk, Russian Federation

St. Petersburg City Oncology Dispensary; 🇷🇺 Saint-Petersburg, Russian Federation

Clinical Hospital Center Bezanijska Kosa; 🇷🇸 Belgrade, Serbia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Atlantic Health Sciences Corporation; 🇨🇦 Saint John, New Brunswick, Canada

Rivercity Hospital Research Centre; 🇦🇺 Auchenflower, Queensland, Australia

A. Gvamichava National Cancer Centre; 🇬🇪 Tbilisi, Georgia

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada

GKNM Hospital; 🇮🇳 Pappanaickenpalayam, Coimbatore, India

Kidwai Memorial Institute of Oncology; 🇮🇳 Bangalore, India

Curie Manavata Cancer Centre; 🇮🇳 Nasik, Maharashtra, India

McGill University, Department of Oncology; 🇨🇦 Montreal, Quebec, Canada

Union Cancer Prevention Centre; 🇬🇪 Tbilisi, Georgia

Shatabdi Hospital; 🇮🇳 Mumbai, India

Palliative Care Launceston General Hospital; 🇦🇺 Launceston, Tasmania, Australia

P3 Research LTD; 🇳🇿 Tauranga, New Zealand

Australian Clinical Research Organisation; 🇦🇺 Kippa Ring, Queensland, Australia

SEAROC Cancer Centre; 🇮🇳 Jaipur, India

Tata Memorial Hospital; 🇮🇳 Mumbai, India

Jehangir Clinical Development Centre Pvt. Ltd.; 🇮🇳 Pune, India

II Oddzia Chorob Pluc z Pododdzialem Chemioterapii; 🇵🇱 Krakow, Poland

Oradea Clinical County Hospital Medical Oncology Department; 🇷🇴 Oradea, Romania

County Hospital Sibiu Medical Oncology Department; 🇷🇴 Sibiu, Romania

Yaroslavl Regional clinical Oncology Hospital; 🇷🇺 Yaroslavl, Russian Federation

Institute of Lung Diseases and TB; 🇷🇸 Belgrade, Serbia

Institute for Pulmonary diseases of Vojvodina; 🇷🇸 Sremska, Serbia

Professor Dr. Al Trestioreanu Institute; 🇷🇴 Bucharest, Romania