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Completed Phase 2 Interventional Results available

Phase 2 Midostaurin in Aggressive Systemic Mastocytosis and Mast Cell Leukemia

ClinicalTrials.gov ID: NCT00233454

Public ClinicalTrials.gov record NCT00233454. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 5:43 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00233454
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Jason Robert Gotlib
Other
Enrollment
26 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2005 (Actual)
Primary completion
Jun 18, 2010 (Actual)
Completion
Apr 16, 2011 (Actual)
Last update posted
Sep 20, 2018

2005 – 2011

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
Stanford University School of Medicine Stanford California 94305 —
Dana Farber Cancer Institute Boston Massachusetts 02115 —
Washington University-St. Louis St Louis Missouri 63110 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00233454, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 20, 2018 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00233454 live on ClinicalTrials.gov.

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