drugset / Trial / NCT03607149
Pemetrexed in Maintenance in Patients With Impaired Renal Function, 2 Dose Calculation Strategies
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pemetrexed | Small molecule | — | — |