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

This study has been completed.
Sponsor:
Information provided by:
Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00866970
First received: March 20, 2009
Last updated: September 10, 2010
Last verified: September 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 Alder Biopharmaceuticals, Inc.:

Primary Outcome Measures:
  • Change in Safety parameters. [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to symptomatic progressions at Weeks 12 and 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866970

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

No publications provided

Responsible Party: Jeffrey T L Smith, MD FRCP, Alder Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00866970     History of Changes
Other Study ID Numbers: ALD518-CLIN-004
Study First Received: March 20, 2009
Last Updated: September 10, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Georgia: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
India: Drugs Controller General of India
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe
Romania: National Medicines Agency

Keywords provided by Alder Biopharmaceuticals, Inc.:
Lung Cancer
Fatigue
Cachexia

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

ClinicalTrials.gov processed this record on October 22, 2014