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Phase 2 Midostaurin in Aggressive Systemic Mastocytosis and Mast Cell Leukemia

NCT00233454 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2018-09-20

Study results available
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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)

Conditions

  • Systemic Mastocytosis, Aggressive (ASM)
  • Leukemia, Mast Cell
  • Hematological Non-mast Cell Lineage Disease (AHNMD)

Interventions

DRUG

Midostaurin

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

Sponsors & Collaborators

Principal Investigators

  • Jason Robert Gotlib · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2010-06-18
Completion
2011-04-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00233454 on ClinicalTrials.gov