Correlating plasma nintedanib concentrations with clinical outcome and toxicity in patients with interstitial lung disease
Recruiting
- Conditions
- Interstitial lung disease
- Registration Number
- NL-OMON25641
- Lead Sponsor
- Erasmus MC dept. of Medical Oncology and dept. of Pulmonology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
• Age 18 years or older;
• Able to understand the written Information and able to give informed consent;
• Planned treatment with nintedanib for any fibrotic ILD according to standard of care.
Exclusion Criteria
A potential subject who is unable to draw blood for study purposes will be excluded.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharnnacokinetics - i.e. trough levels - of nintedanib and clinical outcome {e.g. lung function and frequency of exacerbations)
- Secondary Outcome Measures
Name Time Method - Toxicity of nintedanib<br>- Nintedanib dose and treatment duration<br>- Frequency and type of other variables that could influence nintedanib PK, e.g. comedication, genetic variances in drug metabolizing (CYP) enzymes and drug transporters, and food (supplements).