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NCT Number: NCT00831974

Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis

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.

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Key information

Conditions

Mastocytosis Immune System Diseases Mast Cell Activation Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with documented Indolent systemic mastocytosis with handicap (ISMwh) having at least 2 infiltrated* organs (skin and /or bone-marrow and/or internal organ).
  • Bone-marrow, or skin or internal biopsy-documented mastocytosis and evaluable disease.
  • 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.
  • 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

  • Performance status > 2 (ECOG).
  • Inadequate organ function, except if the abnormalities are due to involvement by mast cells

Treatment and study plan

masitinib (AB1010)

Drug

3 mg/kg/day

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

AB Science

Industry

Registry information

Official study 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)

Important dates

Study start
2004
Primary completion
2007
First posted
Jan 29, 2009
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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