Pemetrexed (Alimta®) in maintenance in patients with impaired renal function: multicenter randomized Phase 4 study comparing two strategies for dose calculatio

Phase 1

• Conditions: Patients with non-small lung cell cancer; MedDRA version: 19.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-002552-24-FR
• Lead Sponsor: Centre Georges François Leclerc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-05
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Patient over 18 years
•patient with a non-small cell lung cancer predominantly non-squamous histologically documented
•Patient planned to start a treatment or ongoing maintenance treatment with pemetrexed
•Neutrophils> 1500 / mm3; platelets> 100,000 / mm3
•Written informed consent signed and dated
•For patients of childbearing age, effective contraception
•Creatinine clearance according to Cockcroft-Gault formula between 70 and 45 mL / min
•PS=0 or 1

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patient contraindicated with pemetrexed treatment
•Patient with symptomatic brain metastases
•Pregnant or nursing women
•Patient under guardianship or submitted to major people protection regime
•Patient not affiliated with a social security scheme (beneficiary or beneficiary)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified