Clinical trial · Interventional
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
NCT00866970CI-TRIAL-00045878completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALD518 | Biological | — | UNRESOLVED |
| Infusion of 0.9% Saline without ALD518 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 1
- description
- ALD518
- interventionNames
- Biological: ALD518
- type
- EXPERIMENTAL
- label
- 2
- description
- ALD518
- interventionNames
- Biological: ALD518
- type
- EXPERIMENTAL
- label
- 3
- description
- ALD518
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.