SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00831974

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

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.

NCT00831974 Mastocytosis
MeSH: Mastocytosis
HPO: Mastocytosis

2 Interventions

Name: masitinib (AB1010)

Description: 3 mg/kg/day

Type: Drug

1

Name: masitinib (AB1010)

Description: 6 mg/kg/day

Type: Drug

2


Primary Outcomes

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: 12 weeks

Secondary Outcomes

Measure: AFIRMM score, reduction of organ infiltration,level of tryptase, reduction on bio markers (TNF╬▒, eosinophils, histamine levels), pharmacokinetic profile of AB1010

Time: 12 weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 D816V

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). --- Asp-816-Val ---

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). --- Asp-816-Val --- --- D816V ---

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. --- D816V ---



HPO Nodes


HPO:
Mastocytosis
Genes 1
KIT