Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia
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
1 other identifier
interventional
124
9 countries
43
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2008
Shorter than P25 for phase_2
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 20, 2009
CompletedFirst Posted
Study publicly available on registry
March 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJuly 9, 2020
September 1, 2017
11 months
March 20, 2009
July 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Safety parameters.
20 weeks
Secondary Outcomes (1)
Time to symptomatic progressions at Weeks 12 and 24
24 weeks
Study Arms (4)
1
EXPERIMENTALALD518
2
EXPERIMENTALALD518
3
EXPERIMENTALALD518
4
PLACEBO COMPARATORNo ALD518
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Behringlead
Study Sites (43)
Rivercity Hospital Research Centre
Auchenflower, Queensland, 4066, Australia
Australian Clinical Research Organisation
Kippa-Ring, Queensland, 4021, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Palliative Care Launceston General Hospital
Launceston, Tasmania, 7250, Australia
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Atlantic Health Sciences Corporation
Saint John, New Brunswick, E2l 4L2, Canada
McGill University, Department of Oncology
Montreal, Quebec, H2W 1S6, Canada
A. Gvamichava National Cancer Centre
Tbilisi, 0177, Georgia
Union Cancer Prevention Centre
Tbilisi, 0177, Georgia
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi, 0186, Georgia
Indira Gandhi Institute of Medical Sciences
Patna, Bihar, India
Dr. Kamakshi Memorial Hospital
Pallikaranai, Chennai, 600100, India
GKNM Hospital
Pappanaickenpalayam, Coimbatore, 641037, India
Curie Manavata Cancer Centre
Nashik, Maharashtra, 422 304, India
Kidwai Memorial Institute of Oncology
Bangalore, 560029, India
Kailash Cancer Hospital and Research Centre
Gujarat, 391760, India
IndoAmerican Cancer Institute & Research Center
Hyderabad, 500034, India
SEAROC Cancer Centre
Jaipur, 302013, India
Orchid Nursing Home
Kolkata, 700 054, India
Tata Memorial Hospital
Mumbai, 400 012, India
Shatabdi Hospital
Mumbai, India
Mahavir Cancer Sansthan
Patna, 801505, India
Jehangir Clinical Development Centre Pvt. Ltd.
Pune, 411 001, India
P3 Research LTD
Tauranga, 31-40, New Zealand
Oddzial Chorob Pluc i Leczenia Raka Pluc
Bydgoszcz, 85-326, Poland
Oddzial Chemioterapii Szpital Morski
Gdynia, 81-519, Poland
II Oddzia Chorob Pluc z Pododdzialem Chemioterapii
Krakow, 31-202, Poland
Oddzial II Chemioterapii Specjalistyczny Szpital
Szczecin, 70-891, Poland
Professor Dr. Al Trestioreanu Institute
Bucharest, 022328, Romania
Professor Dr. I Chiricuta Institute of Oncology and Radiotherapy
Cluj-Napoca, 400015, Romania
Oradea Clinical County Hospital Medical Oncology Department
Oradea, 410032, Romania
County Hospital Sibiu Medical Oncology Department
Sibiu, 550245, Romania
Republic Oncology Dispensary
Ufa, Bashkortostan Republic, 450054, Russia
Territorial Clinical Oncology Dispensary
Krasnodar, Krasnodar Territory, 350040, Russia
Stavropol Territorial Clinical
Pyatigorsk, Stavropol Territory, 357500, Russia
City Clinical Hospital No. 1
Novosibirsk, 630047, Russia
Saint-Petersburg State Medical University, I.P. Pavlov
Saint Petersburg, 197022, Russia
St. Petersburg City Oncology Dispensary
Saint Petersburg, 198255, Russia
Yaroslavl Regional clinical Oncology Hospital
Yaroslavl, 150054, Russia
Institute of Lung Diseases and TB
Belgrade, 11 000, Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade, 11080, Serbia
Clinical Centre Kragujevac
Kragujevac, 34000, Serbia
Institute for Pulmonary diseases of Vojvodina
Sremska, 21 104, Serbia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jeffrey TL Smith, MD FRCP
Alder Biopharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2009
First Posted
March 23, 2009
Study Start
September 1, 2008
Primary Completion
August 1, 2009
Study Completion
December 1, 2009
Last Updated
July 9, 2020
Record last verified: 2017-09