Come gli altri alcaloidi della Vinca, causa arresto mitotico in metafase mediante legame con le proteine microtubulari. Si presenta come un solido amorfo molto solubile in acqua, con p. Identificazione in laboratorio: la sostanza, in soluzione metanolica, assorbe nell'UV alla lunghezza d'onda di nm. Dopo somministrazione endovenosa l'eliminazione plasmatica ha una cinetica di tipo trifasico con emivite rispettivamente di 2 minuti, 1 ora e 24 ore. La vindesina solfato viene usata nella leucemia linfoblastica acuta e nei linfomi Hodgkin e non Hodgkin refrattari ad altri agenti chemioterapici. Viene usata anche in caso di crisi blastiche di leucemie mieloidi croniche, di melanomi maligni refrattari e meno frequentemente in tumori solidi seno, esofago, tratto gastrointestinale, vie aeree superiori, carcinoma broncopolmonare non a piccole cellule.
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Print Download. Examples: Cancer AND drug name. Pneumonia AND sponsor name. How to search [pdf]. For these items you should use the filters and not add them to your search terms in the text field. Print Download Summary. Review by the Competent Authority or Ethics Committee in the country concerned. As of 1. EU Clinical Trials Register. Search tools. Select Date Range: to. Select Rare Disease:.
IMP with orphan designation in the indication. Orphan Designation Number:. Results Status: Trials with results Trials without results. Clear advanced search filters. Date on which this record was first entered in the EudraCT database:. Title of the trial for lay people, in easily understood, i.
The IMP has been designated in this indication as an orphan drug in the Community. Committee on Advanced therapies CAT has issued a classification for this product. Combination product that includes a device, but does not involve an Advanced Therapy. AntiHER2 treatment has to be interrupted at least 4 weeks prior to enrolment. Treatment has to be suspended at least 2 weeks bifore enrolment. The rate of progression-free survival at one year is defined as the proportion of patients from the date of enrollment to the next year had no tumor progression or death from any cause.
For patients with measurable disease at baseline, the progression is determined by reference to the RECIST criteria version 1. In the absence of measurable disease only for patients with metastatic bone progression will be defined as follows: a. Occurrence of one or more new bone lytic lesions b. Occurrence of one or more new lesions outside the bone c.
Unequivocal progression of existing bone metastases. The occurrence of complications related to the presence of bone metastases will not be considered as evidence of disease progression if there are at least one of the three previous criteria.
Time to progression defined as the time between the date of enlistment and the date of documented progression of disease or death from any cause. Duration of response, defined as the time between the date of first documented response complete or partial response and the date on which occurs the first progression or death from any cause.
Will be reported on the incidence of adverse events, serious adverse events and changes from baseline in vital signs and laboratory values. Quality of life. Will be given a specific questionnaire for assessing quality of life. Adherence to treatment. There will be a diary that provides information about vinorelbine and capecitabine therapy, you take them and the problems related to them. Tempo alla progressione definito come il tempo intercorrente tra la data di arruolamento e la data di progressione documentata di malattia o la morte per qualsiasi causa.
Durata della risposta, definita come il tempo intercorrente tra la data della prima documentata risposta risposta parziale o completa e la data in cui si verifica la prima progressione o la morte per qualsiasi causa. Aderenza al trattamento. The trial involves single site in the Member State concerned. Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial.
Plans for treatment or care after the subject has ended the participation in the trial if it is different from the expected normal treatment of that condition. The patient will be followed every 3 months, as per normal medical practice.
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