Clinical trial NCT00866970: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NSCLC
Fatigue
Cachexia
Keywords: Lung Cancer
Fatigue
Cachexia
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2009-03-23
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Safety parameters.
timeFrame: 20 weeks
Secondary outcomes:
measure: Time to symptomatic progressions at Weeks 12 and 24
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Auchenflower
country: Australia
facility: Rivercity Hospital Research Centre
state: Queensland
city: Kippa Ring
country: Australia
facility: Australian Clinical Research Organisation
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Launceston
country: Australia
facility: Palliative Care Launceston General Hospital
state: Tasmania
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Saint John
country: Canada
facility: Atlantic Health Sciences Corporation
state: New Brunswick
city: Montreal
country: Canada
facility: McGill University, Department of Oncology
state: Quebec
city: Tbilisi
country: Georgia
facility: A. Gvamichava National Cancer Centre
city: Tbilisi
country: Georgia
facility: Union Cancer Prevention Centre
city: Tbilisi
country: Georgia
facility: Medulla Chemotherapy and Immunotherapy Clinic
city: Patna
country: India
facility: Indira Gandhi Institute of Medical Sciences
state: Bihar
city: Pallikaranai
country: India
facility: Dr. Kamakshi Memorial Hospital
state: Chennai
city: Pappanaickenpalayam
country: India
facility: GKNM Hospital
state: Coimbatore
city: Nasik
country: India
facility: Curie Manavata Cancer Centre
state: Maharashtra
city: Bangalore
country: India
facility: Kidwai Memorial Institute of Oncology
city: Gujarat
country: India
facility: Kailash Cancer Hospital and Research Centre
city: Hyderabad
country: India
facility: IndoAmerican Cancer Institute & Research Center
city: Jaipur
country: India
facility: SEAROC Cancer Centre
city: Kolkata
country: India
facility: Orchid Nursing Home
city: Mumbai
country: India
facility: Tata Memorial Hospital
city: Mumbai
country: India
facility: Shatabdi Hospital
city: Patna
country: India
facility: Mahavir Cancer Sansthan
city: Pune
country: India
facility: Jehangir Clinical Development Centre Pvt. Ltd.
city: Tauranga
country: New Zealand
facility: P3 Research LTD
city: Bydgoszcz
country: Poland
facility: Oddzial Chorob Pluc i Leczenia Raka Pluc
city: Gdynia
country: Poland
facility: Oddzial Chemioterapii Szpital Morski
city: Krakow
country: Poland
facility: II Oddzia Chorob Pluc z Pododdzialem Chemioterapii
city: Szczecin
country: Poland
facility: Oddzial II Chemioterapii Specjalistyczny Szpital
city: Bucharest
country: Romania
facility: Professor Dr. Al Trestioreanu Institute
city: Cluj-Napoca
country: Romania
facility: Professor Dr. I Chiricuta Institute of Oncology and Radiotherapy
city: Oradea
country: Romania
facility: Oradea Clinical County Hospital Medical Oncology Department
city: Sibiu
country: Romania
facility: County Hospital Sibiu Medical Oncology Department
city: Krasnodar
country: Russian Federation
facility: Territorial Clinical Oncology Dispensary
state: Krasnodar Territory
city: Ufa
country: Russian Federation
facility: Republic Oncology Dispensary
state: Republic Of Bashkortostan
city: Pyatigorsk
country: Russian Federation
facility: Stavropol Territorial Clinical
state: Stavropol Territory
city: Novosibirsk
country: Russian Federation
facility: City Clinical Hospital No. 1
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Medical University, I.P. Pavlov
city: Saint-Petersburg
country: Russian Federation
facility: St. Petersburg City Oncology Dispensary
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional clinical Oncology Hospital
city: Belgrade
country: Serbia
facility: Institute of Lung Diseases and TB
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Bezanijska Kosa
city: Kragujevac
country: Serbia
facility: Clinical Centre Kragujevac
city: Sremska
country: Serbia
facility: Institute for Pulmonary diseases of Vojvodina
Study officials:
affiliation: Alder Biopharmaceuticals, Inc.
name: Jeffrey TL Smith, MD FRCP
role: STUDY_DIRECTOR
References: