Trial | NCT00866970  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    clazakizumab ...

  • Study Participants

    124
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).
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 Started
Sep 30
2008
Primary Completion
Aug 31
2009
Study Completion
Dec 31
2009
Last Update
Jul 09
2020

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

Biological Infusion of 0.9% Saline without ALD518

Infusion of 0.9% Saline without addition of ALD518

1 Experimental

ALD518

2 Experimental

ALD518

3 Experimental

ALD518

4 Placebo Comparator

No ALD518

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
No Results Posted