90
Participants
Start Date
February 7, 2025
Primary Completion Date
June 1, 2026
Study Completion Date
June 1, 2026
Plitidepsin 1.5 mg/day
"Receive 1.5 mg/day of plitidepsin intravenously (IV) over a 1-hour infusion for 3 consecutive days every 15 days during 4 treatment periods.~The participant will receive the following pre-medication before receiving the study treatment:~* Palonosetron 0.25 mg IV~* Dexchlorpheniramine maleate 5 mg IV (or equivalent to H1 receptor antihistamines)~* Famotidine 40 mg oral (60 minutes before starting the plitidepsin/placebo infusion)~* Dexamethasone phosphate 8 mg IV (equivalent to 6.6 mg of dexamethasone)~Premedication should be completed 20-30 minutes before starting the plitidepsin/placebo infusion."
Placebo
"Receive placebo intravenously (IV) over a 1-hour infusion for 3 consecutive days every 15 days during 4 treatment periods.~The participant will receive the following pre-medication before receiving the study treatment:~* Palonosetron 0.25 mg IV~* Dexchlorpheniramine maleate 5 mg IV (or equivalent to H1 receptor antihistamines)~* Famotidine 40 mg oral (60 minutes before starting the plitidepsin/placebo infusion)~* Dexamethasone phosphate 8 mg IV (equivalent to 6.6 mg of dexamethasone)~Premedication should be completed 20-30 minutes before starting the plitidepsin/placebo infusion."
Placebo and Plitidepsin 1.5mg/day
"Receive placebo intravenously (IV) over a 1-hour infusion for 3 consecutive days every 15 days during two treatment periods and receive plitidepsin 1.5mg/day during the last two treatment periods.~The participant will receive the following pre-medication before receiving the study treatment:~* Palonosetron 0.25 mg IV~* Dexchlorpheniramine maleate 5 mg IV (or equivalent to H1 receptor antihistamines)~* Famotidine 40 mg oral (60 minutes before starting the plitidepsin/placebo infusion)~* Dexamethasone phosphate 8 mg IV (equivalent to 6.6 mg of dexamethasone)~Premedication should be completed 20-30 minutes before starting the plitidepsin/placebo infusion."
RECRUITING
Hospital Universitari Germans Trias i Pujol, Badalona
Collaborators (1)
PharmaMar
INDUSTRY
IrsiCaixa
OTHER
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
OTHER