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NCT01316692 · ClinicalTrials.gov registry record · Phase 2
Aurora A Kinase Inhibitor MLN8237 in Treating Patients With Unresectable Stage III-IV Melanoma
A Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT01316692: Clinical Trial Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
NCT01316692 is a Phase 2 study that was terminated before completion, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01316692, a Phase 2 study, was terminated before completion, sponsored by Vanderbilt-Ingram Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
RATIONALE: Aurora A kinase inhibitor MLN8237 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well Aurora A kinase inhibitor MLN8237 works in treating patients with unresectable stage III-IV melanoma Funding Source - FDA OOPD
Primary Outcome
If 2 or more of 23 pts show CR/PR in stage 1, then an additional 33 pts will be enrolled in stage 2. If 6 or more of the total 56 pts show CR/PR at 18 weeks, then further clinical trials will be warranted. Per Response Evaluation Criteria in Solid Tumor (RECIST)1.1: Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Patients are categorized according to the best response achiev
Interventions
- PROCEDURE biopsy
- OTHER mass spectrometry
- GENETIC TdT-mediated dUTP nick end labeling assay
- OTHER laboratory biomarker identification and analysis
- OTHER immunohistochemistry/tissue microarrays
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2011-10 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
Why NCT01316692 stopped before completion
NCT01316692 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 5 interventions - of which biopsy is the first listed.
NCT01316692 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01316692 about?
NCT01316692 is a clinical study titled "Aurora A Kinase Inhibitor MLN8237 in Treating Patients With Unresectable Stage III-IV Melanoma". RATIONALE: Aurora A kinase inhibitor MLN8237 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well Aurora A kinase inhibitor MLN8237 works in treating patients with unresectable stage III-IV melanoma Funding Sou...
What is the current status of trial NCT01316692?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2011-10. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01316692?
The interventions under investigation include: biopsy (PROCEDURE), mass spectrometry (OTHER), TdT-mediated dUTP nick end labeling assay (GENETIC), laboratory biomarker identification and analysis (OTHER), immunohistochemistry/tissue microarrays (OTHER).
Who is sponsoring clinical trial NCT01316692?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01316692's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 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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