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
Verified date | September 2017 |
Source | CSL Behring |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
CSL Behring |
Australia, Canada, Georgia, India, New Zealand, Poland, Romania, Russian Federation, Serbia,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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