The effect of oral folinic acid to prevent pemetrexed induced adverse events.

Phase 1

Recruiting

• Conditions: on small cell lung cancer (NSCLC), Mesothelioma, Thymoma; MedDRA version: 20.0Level: PTClassification code: 10027406Term: Mesothelioma Class: 100000004864; MedDRA version: 21.1Level: PTClassification code: 10059515Term: Non-small cell lung cancer metastatic Class: 100000004864; MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10043670Term: Thymoma Class: 100000004864; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-502345-10-00
• Lead Sponsor: Amphia Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-20
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

=18 years old, Eligible for treatment with pemetrexed-based chemotherapy based on indication., ECOG performance score of 0-2., Subject is able and willing to sign the Informed Consent Form.

Exclusion Criteria

Contraindications for treatment with folinic acid in line with the SmPC. a. Hypersensitivity to the active substance or to any of the excipients. b. Anaemia caused by vitamin B12 deficiency., The presence of clinically relevant drug-drug interactions, according to the current SmPC of folinic acid.

Study & Design

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