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NCT00925132 · ClinicalTrials.gov registry record · Phase 1
Treatment of Resistant Metastatic Melanoma Using Decitabine, Temozolomide and Panobinostat
A Phase 1 study, sponsored by University of Iowa.
- Terminated
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT00925132: Clinical Trial Phase 1 study, sponsored by University of Iowa.
NCT00925132 is a Phase 1 study that was terminated before completion, run by University of Iowa. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00925132, a Phase 1 study, was terminated before completion, sponsored by University of Iowa.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
The purpose of this study is to treat metastatic melanoma with a combination of standard chemotherapy (decitabine and Temozolomide in a dose escalation scheme) with an study drug called panobinostat. This combination is proposed to unlock genes that may contribute to mechanisms that cause tumor growth. The primary objectives of this study are: * To evaluate the safety and tolerability of the proposed schedule of decitabine, temozolomide and panobinostat in the treatment of metastatic melanoma. * To define any Dose Limiting Toxicity (DLT) and maximum tolerated dose (MTD) of the combination of decitabine, temozolomide and panobinostat.
Primary Outcome
A DLT was any Grade 4 toxicity for neutrophils or platelets for ≥ 7 days, Grade 3 toxicity for neutrophils for ≥ 21 days, any Grade 3 solid organ toxicity not explainable by another cause (e.g. neurotoxicity, GI toxicity), metabolic/laboratory toxicity (≥10 x ULN AST) for ≥ 14 days, any Grade 4 infection or QTcF\> 500msec EKG. DLTs were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. All adverse events were collected and graded to determine DLTs as ass
Interventions
- DRUG Temozolomide, Decitabine, Panobinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2009-12 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
Why NCT00925132 stopped before completion
NCT00925132 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which Temozolomide, Decitabine, Panobinostat is the first listed.
NCT00925132 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00925132 about?
NCT00925132 is a clinical study titled "Treatment of Resistant Metastatic Melanoma Using Decitabine, Temozolomide and Panobinostat". The purpose of this study is to treat metastatic melanoma with a combination of standard chemotherapy (decitabine and Temozolomide in a dose escalation scheme) with an study drug called panobinostat. This combination is proposed to unlock genes that may contribute to mechanisms that cause tumor grow...
What is the current status of trial NCT00925132?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2009-12. Estimated completion is 2016-12.
What interventions are being tested in trial NCT00925132?
The interventions under investigation include: Temozolomide, Decitabine, Panobinostat (DRUG).
Who is sponsoring clinical trial NCT00925132?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00925132's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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