Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia
NCT ID: NCT00866970
Last Updated: 2020-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2008-09-30
2009-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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1
ALD518
ALD518
ALD518 80 mg on Day 1, Week 8 and Week 16
2
ALD518
ALD518
ALD518 160 mg IV on Day 1, Week 8 and Week 16
3
ALD518
ALD518
ALD518 360 mg IV on Day 1, Week 8, and Week 16
4
No ALD518
Infusion of 0.9% Saline without ALD518
Infusion of 0.9% Saline without addition of ALD518
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* AST/ALT ≥ 3 x ULN at screening
* Hemoglobin \< 8 g/dL at Screening
* History of or active diagnosis of Tuberculosis
18 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffrey TL Smith, MD FRCP
Role: STUDY_DIRECTOR
Alder Biopharmaceuticals, Inc.
Locations
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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
Nashik, 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
Republic Oncology Dispensary
Ufa, Bashkortostan Republic, Russia
Territorial Clinical Oncology Dispensary
Krasnodar, Krasnodar Territory, Russia
Stavropol Territorial Clinical
Pyatigorsk, Stavropol Territory, Russia
City Clinical Hospital No. 1
Novosibirsk, , Russia
Saint-Petersburg State Medical University, I.P. Pavlov
Saint Petersburg, , Russia
St. Petersburg City Oncology Dispensary
Saint Petersburg, , Russia
Yaroslavl Regional clinical Oncology Hospital
Yaroslavl, , Russia
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
Countries
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Other Identifiers
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ALD518-CLIN-004
Identifier Type: -
Identifier Source: org_study_id
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