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NCT00510289 · ClinicalTrials.gov registry record · Phase 2

Sorafenib in Myelodysplastic Syndrome

A Phase 2 study, sponsored by Duke University.

Terminated
Registry status
Phase 2
Development phase
19
Enrollment target

NCT00510289: Clinical Trial Phase 2 study, sponsored by Duke University.

NCT00510289 is a Phase 2 study that was terminated before completion, run by Duke University. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00510289, a Phase 2 study, was terminated before completion, sponsored by Duke University.

TERMINATED
Registry status
Phase 2
Development phase
19 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy of sorafenib in patients with Myelodysplastic Syndrome (MDS). Eligible subjects will receive Sorafenib administered at 400mg orally twice a day, given on days 1-28 of a 28-day cycle. Patients will be evaluated for hematological response after 2 cycles and then every 3 cycles thereafter for a maximum of 5 years from study entry. If a patient achieves a complete response they may receive an additional 6 cycles of therapy beyond documentation of complete response unless unacceptable toxicity occurs. For patients with partial response, hematological improvement or stable disease they will continue treatment until relapse, progression of disease, or unacceptable toxicity occurs.

Primary Outcome

Hematological response is defined as the number of subjects who achieve either a complete response (CR), Partial response (PR) or Hematologic improvement.(HI). HI is defined as peripheral blood counts with hemoglobin ≥11 g/dL, absolute neutrophil count ≥1x10(9)/L and platelet count ≥100x10(9)/L, and normal bone marrow morphology with no evidence of dysplasia or blasts. CR is defined as the disappearance of all signs and symptoms related to disease, along with HI. PR is defined as fulfilling the

Interventions

  • DRUG Sorafenib

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2006-07
Est. Completion 2011-07
Phase Phase 2
Duke University

1,725 total trials

Why NCT00510289 stopped before completion

NCT00510289 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 1 intervention - of which Sorafenib is the first listed.

NCT00510289 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00510289 about?

NCT00510289 is a clinical study titled "Sorafenib in Myelodysplastic Syndrome". The purpose of this study is to evaluate the efficacy of sorafenib in patients with Myelodysplastic Syndrome (MDS). Eligible subjects will receive Sorafenib administered at 400mg orally twice a day, given on days 1-28 of a 28-day cycle. Patients will be evaluated for hematological response after 2 c...

What is the current status of trial NCT00510289?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2006-07. Estimated completion is 2011-07.

What interventions are being tested in trial NCT00510289?

The interventions under investigation include: Sorafenib (DRUG).

Who is sponsoring clinical trial NCT00510289?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00510289's enrollment target sits among peer trials

19 1894th of 2000 higher than 103 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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Source: ClinicalTrials.gov NCT00510289, the US trial registry maintained by the National Library of Medicine. NCT00510289 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.