A Phase 4 interventional study of Pemetrexed in Non Small Cell Lung Cancer and Mesothelioma, sponsored by Radboud University Medical Center. Completed at 5 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-10.
Sponsored by Radboud University Medical Center · Phase 4, Interventional, and Diagnostic
Rationale:
Pemetrexed is a multi-targeted folate antagonist, which is primarily indicated for the treatment of advanced non-small cell lung cancer (NSCLC) and mesothelioma. Dosing of cytotoxic agents like pemetrexed requires balancing the dual risk of sub-therapy and toxicity. Administration of pemetrexed to patients with a creatinine clearance \<45 ml/min is currently not advised. Pemetrexed is dosed based on body surface area (BSA), while renal function and dose are the sole determinants for systemic exposure. This causes 3 major issues:
The investigators aim to address these problems.
Objective: The overall main objective is to develop a safe and effective individualized dosing regimen for pemetrexed.
Study design: IMPROVE-III is an explorative microdosing study to assess the extrapolability of microdose-pharmacokinetics to the pharmacokinetics of a therapeutic dose.
Study population: IMPROVE-III includes 10 patients of IMPROVE-I and/or IMPROVE-II.
Intervention: patients will be administered a microdose with subsequent pharmacokinetic assessment.
Main study endpoints: The predictive performance of microdosing to predict full dose pharmacokinetics
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 10 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Contraindications for treatment with pemetrexed in line with the summary of product characteristics (SmPC) (except for creatinine clearance \<45 ml/min in IMPROVE-I)
Patients will be administered a microdose of pemetrexed with subsequent pharmacokinetic assessment. Afterwards the patients will continue in either IMPROVE-I or -II for second pharmacokinetic assessment
Drug: Pemetrexed
patients will be administered a microdose with subsequent pharmacokinetic assessment.
Also known as: Microdosing
The predictive performance of microdosing to predict full dose pharmacokinetics
Mean relative prediction error (MPE)
Time frame: 3 months
The predictive performance of microdosing to predict full dose pharmacokinetics
Root mean squared relative prediction error (RMSE)
Time frame: 3 months
Exposure (AUC) after microdose
mg\*h/l
Time frame: 1 day
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center