The effect of oral folinic acid to prevent pemetrexed induced adverse events.
Key facts
- Where
- Breda és Dordrecht, HollandiaSee the 2 sites
- Phase
- 4. fázis
Where in Hollandia
- Amphia HospitalBreda, HollandiaNo longer taking part
- Albert Schweitzer ZiekenhuisDordrecht, HollandiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amphia Hospital
- Trial code
- EU 2022-502345-10-00
- Record updated
- 2023. március 13.
- Original description
The main objective is to evaluate the haematological toxicity in patients who use pemetrexed with and without rescue therapy with folinic acid.Read full original descriptionShow less
The effect of oral folinic acid rescue therapy on pemetrexed induced neutropenia and other toxicity: A randomized open-label trial.
The main objective is to evaluate the haematological toxicity in patients who use pemetrexed with and without rescue therapy with folinic acid.
Inclusion: ≥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: 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.