phase 3 randomisé, en double aveugle, évaluant l’efficacité et la tolérance du masitinib, chez des patients ayant une mastocytose systémique ou cutané

source:
1:   http://www.e-cancer.fr/en/recherche/clinical-research/clinical-trial-register/clinical-trial-register/details-etude?idFiche=1024
2:  http://clinicaltrials.gov/show/NCT00814073

AB SCIENCE AB06006 : Essai de phase 3 randomisé, en double aveugle, évaluant l’efficacité et la tolérance du masitinib, chez des patients ayant une mastocytose systémique ou cutané. [Informations issues du site clinicaltrials.gov et traduites par l'INCa]

http://euroscan.org.uk/technologies/technology/view/2415

Trial: NCT00814073, AB06006; masitinib vs placebo; phase III.
Sponsor: AB Science.
Status: Ongoing.
Source of information: Trial registry(18).
Location: EU (inc UK), USA and India.
Design: Randomised, placebo-controlled.
Participants: n=200 (planned); aged 18 years and older; smouldering systemic, indolent systemic, or cutaneous mastocytosis with handicap.
Schedule: Randomised to masitinib 6mg/kg oral, or placebo oral, both once daily.
Follow-up: Active treatment period 24 weeks. Patients who benefit from study treatment can enter extension phase until serious adverse events or lack of efficacy.
Primary outcome/s: Responder rate at week 24.
Secondary outcome/s: Pruritus score; number of flushes per day; pollakiuria; number of stools per day; quality of life (QoL) C-30 score; Hamilton rating scale for depression score.
Key results: -
Adverse effects (AEs): Common AEs include: nausea/vomiting, 52%; oedema, 44%; muscle spasms, 28%; rash, 28%;abdominal pain, 16%; diarrhoea, 12%; headache, 20%.
Expected reporting date: Estimated study completion date reported as June 2014