Status:
UNKNOWN
Folinic Acid for Prevention of Pemetrexed-induced Toxicity
Lead Sponsor:
Amphia Hospital
Collaborating Sponsors:
Albert Schweitzer Hospital
Conditions:
NSCLC
Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Objective The main objective is to evaluate the haematological toxicity in patients who use pemetrexed with and without rescue therapy with folinic acid. Primary endpoint Difference between treatment...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in this study, a subject must meet all of the following 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
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Contraindications for treatment with folinic acid in line with the SmPC.
- Hypersensitivity to the active substance or to any of the excipients.
- Anaemia caused by vitamin B12 deficiency.
- The presence of clinically relevant drug-drug interactions, according to the current SmPC of folinic acid.
Exclusion
Key Trial Info
Start Date :
February 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06010277
Start Date
February 6 2023
End Date
January 1 2024
Last Update
August 24 2023
Active Locations (2)
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1
Amphia Hospital
Breda, North Brabant, Netherlands, 4817
2
Albert Schweitzer Hospital
Dordrecht, South Holland, Netherlands, 3318