Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia

July 7, 2020 updated by: CSL Behring

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Rivercity Hospital Research Centre
      • Kippa Ring, Queensland, Australia, 4021
        • Australian Clinical Research Organisation
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Palliative Care Launceston General Hospital
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Atlantic Health Sciences Corporation
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University, Department of Oncology
  • Georgia
      • Tbilisi, Georgia, 0186
        • Medulla Chemotherapy and Immunotherapy Clinic
      • Tbilisi, Georgia, 0177
        • A. Gvamichava National Cancer Centre
      • Tbilisi, Georgia, 0177
        • Union Cancer Prevention Centre
  • India
      • Bangalore, India, 560029
        • Kidwai Memorial Institute of Oncology
      • Gujarat, India, 391760
        • Kailash Cancer Hospital and Research Centre
      • Hyderabad, India, 500034
        • IndoAmerican Cancer Institute & Research Center
      • Jaipur, India, 302013
        • SEAROC Cancer Centre
      • Kolkata, India, 700 054
        • Orchid Nursing Home
      • Mumbai, India, 400 012
        • Tata Memorial hospital
      • Mumbai, India
        • Shatabdi Hospital
      • Patna, India, 801505
        • Mahavir Cancer Sansthan
      • Pune, India, 411 001
        • Jehangir Clinical Development Centre Pvt. Ltd.
    • Bihar
      • Patna, Bihar, India
        • Indira Gandhi Institute of Medical Sciences
    • Chennai
      • Pallikaranai, Chennai, India, 600100
        • Dr. Kamakshi Memorial Hospital
    • Coimbatore
      • Pappanaickenpalayam, Coimbatore, India, 641037
        • GKNM Hospital
    • Maharashtra
      • Nasik, Maharashtra, India, 422 304
        • Curie Manavata Cancer Centre
  • New Zealand
      • Tauranga, New Zealand, 31-40
        • P3 Research Ltd
  • Poland
      • Bydgoszcz, Poland, 85-326
        • Oddzial Chorob Pluc i Leczenia Raka Pluc
      • Gdynia, Poland, 81-519
        • Oddzial Chemioterapii Szpital Morski
      • Krakow, Poland, 31-202
        • II Oddzia Chorob Pluc z Pododdzialem Chemioterapii
      • Szczecin, Poland, 70-891
        • Oddzial II Chemioterapii Specjalistyczny Szpital
  • Romania
      • Bucharest, Romania, 022328
        • Professor Dr. Al Trestioreanu Institute
      • Cluj-Napoca, Romania, 400015
        • Professor Dr. I Chiricuta Institute of Oncology and Radiotherapy
      • Oradea, Romania, 410032
        • Oradea Clinical County Hospital Medical Oncology Department
      • Sibiu, Romania, 550245
        • County Hospital Sibiu Medical Oncology Department
  • Russian Federation
      • Novosibirsk, Russian Federation, 630047
        • City Clinical Hospital No. 1
      • Saint-Petersburg, Russian Federation, 197022
        • Saint-Petersburg State Medical University, I.P. Pavlov
      • Saint-Petersburg, Russian Federation, 198255
        • St. Petersburg City Oncology Dispensary
      • Yaroslavl, Russian Federation, 150054
        • Yaroslavl Regional Clinical Oncology Hospital
    • Krasnodar Territory
      • Krasnodar, Krasnodar Territory, Russian Federation, 350040
        • Territorial Clinical Oncology Dispensary
    • Republic Of Bashkortostan
      • Ufa, Republic Of Bashkortostan, Russian Federation, 450054
        • Republic Oncology Dispensary
    • Stavropol Territory
      • Pyatigorsk, Stavropol Territory, Russian Federation, 357500
        • Stavropol Territorial Clinical
  • Serbia
      • Belgrade, Serbia, 11080
        • Clinical Hospital Center Bezanijska Kosa
      • Belgrade, Serbia, 11 000
        • Institute of Lung Diseases and TB
      • Kragujevac, Serbia, 34000
        • Clinical Centre Kragujevac
      • Sremska, Serbia, 21 104
        • Institute for pulmonary diseases of Vojvodina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
ALD518
Biological: ALD518
ALD518 80 mg on Day 1, Week 8 and Week 16
Biological: ALD518
ALD518 160 mg IV on Day 1, Week 8 and Week 16
Biological: ALD518
ALD518 360 mg IV on Day 1, Week 8, and Week 16
Experimental: 2
ALD518
Biological: ALD518
ALD518 80 mg on Day 1, Week 8 and Week 16
Biological: ALD518
ALD518 160 mg IV on Day 1, Week 8 and Week 16
Biological: ALD518
ALD518 360 mg IV on Day 1, Week 8, and Week 16
Experimental: 3
ALD518
Biological: ALD518
ALD518 80 mg on Day 1, Week 8 and Week 16
Biological: ALD518
ALD518 160 mg IV on Day 1, Week 8 and Week 16
Biological: ALD518
ALD518 360 mg IV on Day 1, Week 8, and Week 16
Placebo Comparator: 4
No ALD518
Biological: Infusion of 0.9% Saline without ALD518
Infusion of 0.9% Saline without addition of ALD518

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Safety parameters.
Time Frame: 20 weeks
20 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to symptomatic progressions at Weeks 12 and 24
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSL Behring

Investigators

  • Study Director: Jeffrey TL Smith, MD FRCP, Alder Biopharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

March 20, 2009

First Submitted That Met QC Criteria

March 20, 2009

First Posted (Estimate)

March 23, 2009

Study Record Updates

Last Update Posted (Actual)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALD518-CLIN-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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