At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 116 enrolled
Drug / intervention
Midostaurin (PKC412)drug
Likely dose
Midostaurin (PKC412) 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single Arm, Phase II, Open-Label Study to Determine the Efficacy of 100mg Twice Daily Oral Dosing of Midostaurin Administered to Patients With Aggressive Systemic Mastocytosis or Mast Cell Leukemia +/- an Associated Hematological Clonal Non-Mast Cell Lineage Disease
In Brief
A Phase 2 clinical trial evaluating Midostaurin (PKC412) for Leukemia. Completed, enrolled 116 participants across 29 sites in 12 countries.
Detailed Summary
The purpose of this study was to determine the efficacy and safety of twice daily (bid) oral midostaurin in patients with Aggressive Systemic Mastocytosis (ASM) or Mast Cell Leukemia (MCL) with or without an Associated Hematological clonal Non-Mast cell lineage Disease (AHNMD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Netherlands, Norway, Poland, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2008
First PostedOct 2008
Primary CompletionDec 2014
Study CompletionAug 2017
TodayJul 2026
First PostedOct 29, 2008
Enrollment StartOct 13, 2008
Primary CompletionDec 1, 2014
Study CompletionAug 24, 2017
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 17.7 years ago
Interventions
Midostaurin (PKC412)drug
Midostaurin was provided as 25 mg soft gelatin capsules for oral administration.