Spots Global Cancer Trial Database for Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia
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Trial Identification
Brief Title: Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia
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
Study ID: NCT00866970
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Rivercity Hospital Research Centre, Auchenflower, Queensland, Australia
Australian Clinical Research Organisation, Kippa Ring, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Palliative Care Launceston General Hospital, Launceston, Tasmania, Australia
Cross Cancer Institute, Edmonton, Alberta, Canada
Atlantic Health Sciences Corporation, Saint John, New Brunswick, Canada
McGill University, Department of Oncology, Montreal, Quebec, Canada
A. Gvamichava National Cancer Centre, Tbilisi, , Georgia
Union Cancer Prevention Centre, Tbilisi, , Georgia
Medulla Chemotherapy and Immunotherapy Clinic, Tbilisi, , Georgia
Indira Gandhi Institute of Medical Sciences, Patna, Bihar, India
Dr. Kamakshi Memorial Hospital, Pallikaranai, Chennai, India
GKNM Hospital, Pappanaickenpalayam, Coimbatore, India
Curie Manavata Cancer Centre, Nasik, Maharashtra, 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
Tata Memorial Hospital, Mumbai, , India
Shatabdi Hospital, Mumbai, , India
Mahavir Cancer Sansthan, Patna, , India
Jehangir Clinical Development Centre Pvt. Ltd., Pune, , India
P3 Research LTD, Tauranga, , New Zealand
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, , Poland
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, , 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
City Clinical Hospital No. 1, Novosibirsk, , Russian Federation
Saint-Petersburg State Medical University, I.P. Pavlov, Saint-Petersburg, , Russian Federation
St. Petersburg City Oncology Dispensary, Saint-Petersburg, , Russian Federation
Yaroslavl Regional clinical Oncology Hospital, Yaroslavl, , Russian Federation
Institute of Lung Diseases and TB, Belgrade, , Serbia
Clinical Hospital Center Bezanijska Kosa, Belgrade, , Serbia
Clinical Centre Kragujevac, Kragujevac, , Serbia
Institute for Pulmonary diseases of Vojvodina, Sremska, , Serbia
Contact Details
Name: Jeffrey TL Smith, MD FRCP
Affiliation: Alder Biopharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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