CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Midostaurindrug
Likely dose
Midostaurin, twice daily oral dosingAI-extracted
Key inclusion· 6
  • ✓Age ≥18 years
  • ✓Karnofsky performance status >30% (equivalent to ECOG 0-3)
  • ✓Histologically confirmed aggressive systemic mastocytosis (ASM) or mast cell leukemia (MCL) with evidence of mast cell infiltration and bone marrow involvement
  • ✓Confirmed tissue sample available within 6 months prior to study entry for KIT mutation status evaluation
Key exclusion· 11
  • ✕Active pulmonary disease unrelated to mastocytosis or new pulmonary infiltrate within 4 weeks (pleural effusion related to mastocytosis may be allowed)
  • ✕Cardiovascular disease, including congestive heart failure
  • ✕Myocardial infarction within 6 months
  • ✕Poorly-controlled hypertension with Grade 3/4 cardiac problems per NYHA criteria

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00233454
NCT00233454Phase 2Completed
CompareCT.gov

A Single Arm, Phase 2, Open-Label Study to Determine the Efficacy of Twice Daily Oral Dosing of PKC412 <Midostaurin> Administered to Patients With Aggressive Systemic Mastocytosis (ASM) and Mast Cell Leukemia (MCL)

Jason Robert Gotlib·interventional·Posted Oct 5, 2005·Updated Sep 20, 2018

In Brief

A Phase 2 clinical trial evaluating Midostaurin for Systemic Mastocytosis, Aggressive (ASM) and 2 related conditions. Completed, enrolled 26 participants across 3 sites.

Detailed Summary

The safety and efficacy of midostaurin (PKC412), a novel investigational drug, will be evaluated on the basis of response rate, when administered to patients with aggressive systemic mastocytosis (ASM) or mast cell leukemia (MCL)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Mastocytosis, Aggressive (ASM), Leukemia, Mast Cell, Hematological Non-mast Cell Lineage Disease (AHNMD)
CountriesUnited States
CollaboratorsNovartis, Novartis Pharmaceuticals

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 5, 2005
Enrollment StartMar 1, 2005
Primary CompletionJun 18, 2010
Study CompletionApr 16, 2011
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 20.7 years ago

Interventions

Midostaurindrug

Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR