Spots Global Cancer Trial Database for Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis
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Trial Identification
Brief Title: Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis
Official Title: Phase IIa, Open-label, Randomized Study of Oral AB1010 in Patients With Systemic Indolent Mastocytosis With Handicap and Not Bearing Activating Point Mutations in the Phosphotransferase Domain of c-Kit Such as the Main Mutation Asp-816-Val (D816V)
Study ID: NCT00831974
Conditions
Study Description
Brief Summary: This is a 12 weeks study aimed at assessing the safety and efficacy of 2 doses of AB1010 in patients suffering from indolent systemic mastocytosis with handicap.
Detailed Description: Efficacy will be assessed based on: Pruritus score Number of flush per day Pollakyuria (on a daily basis) Number of stools per day QLQ-C30 score Hamilton Rating Scale for depression
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Olivier Lortholary, MD, PhD
Affiliation: Hôpital Necker, Paris, France
Role: PRINCIPAL_INVESTIGATOR
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