Clinical trial · Interventional
Validation of an Adjusted Dosing Algorithm of Carboplatin
Pharmacokinetics of Carboplatin After Adjusted Dosing for High BMI, Low Serum Creatinine, and Maximal Renal Function
NCT02103244CI-TRIAL-00014175unknownPhase 4ClinicalTrials.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)
An adjusted dosing algorithm for the dosing of the anticancer drug carboplatin has been developed, that accounts for high BMI, low serum creatinine values and maximal calculated renal function. The hypothesis is that this new dosing algorithm provides a more accurate and safe dose than dosing according to the old standard of care.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- carboplatin
- description
- An adjusted dosing algorithm will be applied to calculate the dose of carboplatin. in 24 patients blood will be obtained in order to determine the pharmacokinetics of carboplatin after adjusted dosing
- interventionNames
- Drug: Carboplatin
Primary outcomes (1)
- measure
- to the determine the mean absolute precision error and the mean prediction error of the AUC of carboplatin after dosing carboplatin according to the new dosing algorithm
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- Assessment of the incidence and severity of all adverse events that occurred during treatment with carboplatin
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically or cytologically proven advanced NSCLC, SCLC or ovarian cancer * to be treated with carboplatin with a target AUC of 4, 5 or 6 * age 18 years or older * WHO performance status 0 - 2 * adequate bone marrow and liver function defined as * haemoglobin ≥ 6.0 mmol/L * white blood cell count ≥ 3.0 \* 109/L * absolute neutrophil count (ANC) ≥ 1.5 \* 109/L * platelets ≥ 100/L * bilirubin ≤ 1.5 times ULN * ALAT and ASAT ≤ 2.5 times ULN (in case of liver metastases ≤ 5.0 times ULN). * estimated life expectancy of at least 12 weeks Exclusion Criteria: * Treatment with carboplatin with a target AUC of \<4 * active clinically serious infection * history of a kidney allograft * pregnant * patients not suitable for follow-up * pregnancy or breast-feeding
References
Publications (0)
Data not yet available
No reference posted for this study.