Clinical trial · Observational
Validation of a Kinetic Model of Erlotinib
NCT02904850CI-TRIAL-00023930unknownClinicalTrials.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)
Several arguments are in favor of a therapeutic monitoring for the erlotinib, therefore, a pharmacokinetic (PK) has been prepared using data from the literature. This model must be validated at concentrations achieved in practice. This is a preliminary study before the implementation of a randomized trial confirming the therapeutic monitoring of erlotinib through this model.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| group of patients | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- group of patients
- description
- Plasma dosage of erlotinib and OSI-420
- interventionNames
- Biological: group of patients
Primary outcomes (1)
- measure
- Difference between plasma concentrations of erlotinib concentrations observed and predictive model
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- Correlation of Blood levels outsized with severe side effects or compromising the vital prognosis (treatment response, adherence (assessed by the test Morisky Green)
- timeFrame
- 1 year
- description
- Evaluation of interest to assay the active metabolite OSI-420 Observation between incidence of clinical problems (ineffectiveness, toxicity, adherence) and blood concentrations of erlotinib outsized. Evaluation of the potential clinical benefit to provide a dosage of erlotinib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients receiving treatment with erlotinib monotherapy for locally advanced or metastatic NSCLC either first line in patients with an activating mutation of the receptor EGF-R or patients with stable disease after 4 cycles of standard first-line chemotherapy with platinum or after failure of at least one prior chemotherapy regimen * Age\> 18 years * Subject has signed an informed consent * Treatment initiated for at least 7 days or dosage changed for at least 7 days Exclusion Criteria: * Contraindication to the use of drug * Subject to exclusion period (as determined by a previous study or in progress) * Inability to give informed information (subject in emergency situations, difficulties in understanding the subject, ...) * Subject under judicial protection * Subject under tutorship or curatorship * Pregnancy (and woman of childbearing age without contraception) * Breastfeeding
References
Publications (0)
Data not yet available
No reference posted for this study.