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NCT00233454 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Midostaurin in Aggressive Systemic Mastocytosis and Mast Cell Leukemia
A Phase 2 study, sponsored by Jason Robert Gotlib.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT00233454: Completed Phase 2 study, sponsored by Jason Robert Gotlib.
NCT00233454 is a Phase 2 study that has completed, run by Jason Robert Gotlib. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00233454, a Phase 2 study, has completed, sponsored by Jason Robert Gotlib.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study 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)
Primary Outcome
Clinical Response \[PR + CR\] will be assessed after 2 cycles of treatment, with each cycle being 28 days (4 weeks) in length. Except as otherwise noted, the minimum criteria for PR is improvement by at least 50% from the baseline value towards the indicated value for one or more of the criteria below: BONE MARROW \& BLOOD * ANC \<1000/uL * Hb \<10 g/dL * Platelets \>100,000/uL LIVER * If hepatomegaly with ascites, decrease in frequency of paracenteses by 50% * Elevated enzyme levels \> upper
Interventions
- DRUG Midostaurin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2005-03 |
| Est. Completion | 2011-04-16 |
| Phase | Phase 2 |
What the finished NCT00233454 record still lists
NCT00233454 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Midostaurin is the first listed.
NCT00233454 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00233454 about?
NCT00233454 is a clinical study titled "Phase 2 Midostaurin in Aggressive Systemic Mastocytosis and Mast Cell Leukemia". 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)
What is the current status of trial NCT00233454?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2005-03. Estimated completion is 2011-04-16.
What interventions are being tested in trial NCT00233454?
The interventions under investigation include: Midostaurin (DRUG).
Who is sponsoring clinical trial NCT00233454?
This trial is sponsored by Jason Robert Gotlib, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00233454's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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