Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis
NCT ID: NCT00831974
Last Updated: 2018-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
23 participants
INTERVENTIONAL
2004-10-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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2
masitinib (AB1010) 6 mg/kg/day
masitinib (AB1010)
6 mg/kg/day
1
masitinib (AB1010) 3 mg/kg/day
masitinib (AB1010)
3 mg/kg/day
Interventions
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masitinib (AB1010)
3 mg/kg/day
masitinib (AB1010)
6 mg/kg/day
Eligibility Criteria
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Inclusion Criteria
2. Bone-marrow, or skin or internal biopsy-documented mastocytosis and evaluable disease.
3. The absence of an activating point mutation in the phosphotransferase domain of c-Kit such as D816V c-Kit mutation in at least one of the two infiltrated organs: bone marrow and/or skin and/or other tissue.
4. Handicap defined as at least one of the following handicaps:
* a number of flush per day ≥ 1 ,
* a pruritus score ≥ 9 ,
* a number of stools per day ≥ 4 ,
* a Pollakyuria (on a per day basis) ≥ 8 ,
* a QLQ-C30 score ≥ 83 ,
* a Hamilton rating scale for depression ≥ 12
Exclusion Criteria
2. Inadequate organ function, except if the abnormalities are due to involvement by mast cells
18 Years
ALL
No
Sponsors
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AB Science
INDUSTRY
Responsible Party
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Principal Investigators
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Olivier Lortholary, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Necker, Paris, France
References
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Paul C, Sans B, Suarez F, Casassus P, Barete S, Lanternier F, Grandpeix-Guyodo C, Dubreuil P, Palmerini F, Mansfield CD, Gineste P, Moussy A, Hermine O, Lortholary O. Masitinib for the treatment of systemic and cutaneous mastocytosis with handicap: a phase 2a study. Am J Hematol. 2010 Dec;85(12):921-5. doi: 10.1002/ajh.21894.
Other Identifiers
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AB04010
Identifier Type: -
Identifier Source: org_study_id