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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00866970
First Posted: March 23, 2009
Last Update Posted: September 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vitaeris INC
  Purpose
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).

Condition Intervention Phase
NSCLC Fatigue Cachexia Biological: ALD518 Biological: Infusion of 0.9% Saline without ALD518 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Vitaeris INC:

Primary Outcome Measures:
  • Change in Safety parameters. [ Time Frame: 20 weeks ]

Secondary Outcome Measures:
  • Time to symptomatic progressions at Weeks 12 and 24 [ Time Frame: 24 weeks ]

Enrollment: 124
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ALD518
Biological: ALD518
ALD518 80 mg on Day 1, Week 8 and Week 16
Experimental: 2
ALD518
Biological: ALD518
ALD518 160 mg IV on Day 1, Week 8 and Week 16
Experimental: 3
ALD518
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00866970


  Show 43 Study Locations
Sponsors and Collaborators
Vitaeris INC
Investigators
Study Director: Jeffrey TL Smith, MD FRCP Alder Biopharmaceuticals, Inc.
  More Information

Responsible Party: Vitaeris INC
ClinicalTrials.gov Identifier: NCT00866970     History of Changes
Other Study ID Numbers: ALD518-CLIN-004
First Submitted: March 20, 2009
First Posted: March 23, 2009
Last Update Posted: September 26, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vitaeris INC:
Lung Cancer
Fatigue
Cachexia

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Fatigue
Cachexia
Wasting Syndrome
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Signs and Symptoms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders