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Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis

This study has been completed.
Sponsor:
Information provided by:
AB Science
ClinicalTrials.gov Identifier:
NCT00831974
First received: January 28, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted

January 28, 2009
January 28, 2009
October 2004
February 2007   (final data collection date for primary outcome measure)
Response 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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
AFIRMM score, reduction of organ infiltration,level of tryptase, reduction on bio markers (TNFα, eosinophils, histamine levels), pharmacokinetic profile of AB1010 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis
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)

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.

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Mastocytosis
  • Drug: masitinib (AB1010)
    3 mg/kg/day
  • Drug: masitinib (AB1010)
    6 mg/kg/day
  • Experimental: 2
    masitinib (AB1010) 6 mg/kg/day
    Intervention: Drug: masitinib (AB1010)
  • Experimental: 1
    masitinib (AB1010) 3 mg/kg/day
    Intervention: Drug: masitinib (AB1010)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
Not Provided
February 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with documented Indolent systemic mastocytosis with handicap (ISMwh) having at least 2 infiltrated* organs (skin and /or bone-marrow and/or internal organ).
  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:

  1. Performance status > 2 (ECOG).
  2. Inadequate organ function, except if the abnormalities are due to involvement by mast cells
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00831974
AB04010
No
Alain Moussy, AB Science
AB Science
Not Provided
Principal Investigator: Olivier Lortholary, MD, PhD Hôpital Necker, Paris, France
AB Science
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP