Clinical trial · Interventional
Pemetrexed in Maintenance in Patients With Impaired Renal Function, 2 Dose Calculation Strategies
Pemetrexed in Maintenance in Patients With Impaired Renal Function: Randomized Phase 4 Multicenter Study Comparing 2 Dose Calculation Strategies (PKAPIR)
- 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)
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.
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- STANDARD ARM
- description
- Calculation of the dose of pemetrexed as a function of body surface area
- interventionNames
- Drug: Pemetrexed
- type
- EXPERIMENTAL
- label
- EXPERIMENTAL ARM
- description
- Calculation of the pemetrexed dose as a function of the Clearance of creatine (CrCLCG)
- interventionNames
- Drug: Pemetrexed
Primary outcomes (1)
- measure
- Median time until treatment is stopped due to renal function ≤ 45mL / min
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient over 18 years of age * Patient with non-small cell lung cancer predominantly non-epidermoid histologically documented * Patient who is scheduled to initiate treatment or undergoing maintenance therapy by pemetrexed * Neutrophils\> 1500 / mm3; Chips\> 100,000 / mm3 * Informed, dated and signed consent For patients of childbearing age, effective contraceptive method * Creatinine clearance according to the Cockcroft-Gault formula between 70 and 45 mL / min * PS = 0 or 1 Exclusion Criteria: * Patient with a contraindication to pemetrexed therapy * Patient with symptomatic brain metastases * Pregnant or nursing women * Patient under guardianship or curatorship or subject to a system of protection for persons of full age * Patient not affiliated to a social security scheme (beneficiary or beneficiary)
References
Publications (0)
Data not yet available