drugset / Trial / NCT03607149

Pemetrexed in Maintenance in Patients With Impaired Renal Function, 2 Dose Calculation Strategies

NCT03607149

Phase 4 Completed 11 enrolled Centre Georges Francois Leclerc
RandomizedParallel-groupOpen-labelTreatment

Summary

Pemetrexed is used in the treatment of non-small cell lung cancer (NSCLC). Its elimination is mainly renal and its nephrotoxicity requires an interruption of treatment when the CrCLCG falls below 45 mL / min. Patients with NSCLC frequently have impaired renal function by other cytotoxic drugs. The dose adjustment of pemetrexed is performed as a function of body surface area (SC) without any pharmacokinetic rational. The challenge is to treat patients with renal insufficiency (RR) with a safe dose, based on CRCL, providing equivalent biological exposure to patients with preserved renal function.

Timeline

Start
2017-04-06
Primary completion
2020-02-20
Completion
2020-02-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Pemetrexed Small molecule