Dose Optimization and Efficacy Assessment of a Fluoropyrimidine Antidote

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

July 31, 2025

Primary Completion Date

July 31, 2028

Study Completion Date

July 31, 2028

Conditions
CancerToxicity Due to Chemotherapy
Interventions
DRUG

I-01/23

The I-01/23 will be administered over a 5-day period, with dosing adjusted according to the patient's body surface area (BSA).

Trial Locations (5)

Unknown

Instituto D'Or de Pesquisa e Ensino de Salvador, Salvador

Instituto D'Or de Pesquisa e Ensino de Brasília, Brasília

Instituto D'Or de Pesquisa e Ensino de Curitiba, Curitiba

Instituto D'Or de Pesquisa e Ensino do Rio de Janeiro, Rio de Janeiro

Instituto D'Or de Pesquisa e Ensino de São Paulo, São Paulo

All Listed Sponsors
collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

lead

D'Or Institute for Research and Education

OTHER