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NCT00818649 · ClinicalTrials.gov registry record · Phase 2
Bortezomib and Vorinostat in Treating Patients With High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia
A Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Terminated
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT00818649: Clinical Trial Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT00818649 is a Phase 2 study that was terminated before completion, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00818649, a Phase 2 study, was terminated before completion, sponsored by Masonic Cancer Center, University of Minnesota.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
RATIONALE: Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with vorinostat may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with vorinostat works in treating patients with high-risk myelodysplastic syndrome or acute myelogenous leukemia.
Primary Outcome
Assessed by the International Working Group response criteria: Complete Remission - \<5% myeloblasts with normal maturation of all cell lines; Partial Remission - bone marrow blasts decreased by \> 50% over pre-treatment but still \>5%; and Hematologic Improvement - hemoglobin increase by \> 1.5g/dl or decreased transfusions by at least 4/8 week period, platelet absolute increase of \>30 X 10\^9/L for those starting at \>20 X 10\^9/L . For those \< 20 X 10\^9 /L at baseline increase by 100%.
Interventions
- DRUG vorinostat
- DRUG bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2009-01 |
| Est. Completion | 2012-05 |
| Phase | Phase 2 |
Why NCT00818649 stopped before completion
NCT00818649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which vorinostat is the first listed.
NCT00818649 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00818649 about?
NCT00818649 is a clinical study titled "Bortezomib and Vorinostat in Treating Patients With High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia". RATIONALE: Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with vorinostat may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with vorinostat works ...
What is the current status of trial NCT00818649?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2009-01. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00818649?
The interventions under investigation include: vorinostat (DRUG), bortezomib (DRUG).
Who is sponsoring clinical trial NCT00818649?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00818649's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 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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