Clinical trial · Observational
Pharmacokinetics of Paclitaxel in Correlation With Adverse Events in Cancer Patients With and Without Liver Impairment
Effect of CYP3A4 and CYP2C8 Activity on Pharmacokinetics of Paclitaxel, Correlation With Adverse Events in Cancer Patients With and Without Liver Impairment
NCT04863144CI-TRIAL-00051509unknownClinicalTrials.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 study aims to assess the pharmacokinetics of paclitaxel and its two major metabolites in patients with normal and impaired liver functions.
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 |
|---|---|---|---|
| Liver Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood samples | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- plasma concentrations of paclitaxel
- timeFrame
- predose till 6 hours post infusion of paclitaxel
- description
- determination of plasma concentration and pharmacokinetic analysis of paclitaxel
- measure
- plasma concentrations of 6-α-hydroxypaclitaxel
- timeFrame
- predose till 6 hours post infusion of paclitaxel
- description
- determination of plasma concentration and pharmacokinetic analysis of 6-α-hydroxypaclitaxel
- measure
- plasma concentrations of 3'-p-hydroxypaclitaxel
- timeFrame
- predose till 6 hours post infusion of paclitaxel
- description
- determination of plasma concentration and pharmacokinetic analysis of 3'-p-hydroxypaclitaxel
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically proven non haematopoietic malignancy (ovarian, breast and lung cancer). * Age between 18 and 70 years * At least a 4-week interval between the last dose of previous chemotherapy protocol and registration (6 weeks in case of treatment with carboplatin). * Glomerular filtration rate \> 60 ml/min * An Eastern Cooperative Oncology Group performance status 0-2, a life expectancy of \> 12 weeks, adequate bone marrow function \[absolute neutrophil count (ANC) ≥ 1 X 109 and platelets ≥ 100 X 109\] * Patient accessible for treatment and follow-up and written informed consent. Exclusion Criteria: * Prior treatment with paclitaxel or other taxanes. * Pre-existing motor or sensory neurotoxicity \> grade 2 according to World Health Organization (WHO) criteria. * Active infection or other serious underlying medical condition (including prior allergic reactions to Paclitaxel or the drug's constituents), dementia or significantly altered mental status, symptomatic brain or liver metastases, history of atrial or ventricular arrhythmias or congestive heart failure even if medically controlled, history of clinical and electrocardiographically documented myocardial infarction. * Simultaneous use of any medication, dietary supplements, or other compounds known to inhibit affect the pharmacokinetics of paclitaxel. * Patients with difficult blood sampling.
References
Publications (0)
Data not yet available
No reference posted for this study.