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NCT01701037 · ClinicalTrials.gov registry record · Phase 2
Dabrafenib Alone and in Combination With Trametinib Before Surgery in Treating Patients With Locally or Regionally Advanced Melanoma That Can Be Removed By Surgery
A Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT01701037: Clinical Trial Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
NCT01701037 is a Phase 2 study that was terminated before completion, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01701037, a Phase 2 study, was terminated before completion, sponsored by Vanderbilt-Ingram Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
This phase II trial studies how well giving dabrafenib alone and in combination with trametinib before surgery works in treating patients with advanced melanoma that can be removed by surgery. Studying samples of tumor tissue in the laboratory from patients receiving dabrafenib and trametinib may help doctors learn more about the effects of these drugs on cells and help identify biomarkers that determine which patients will respond to these drugs best.
Primary Outcome
Tumor response is defined as greater than 30% reduction from baseline in tumor volume by RECIST criteria. To determine whether a patient is responded at day 14, the patient must have the tumor volume evaluated at both baseline and day 14. The tumor response rate is calculated as the proportion of patients responded among all evaluated patients.
Interventions
- OTHER laboratory biomarker analysis
- DRUG dabrafenib
- DRUG trametinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
Why NCT01701037 stopped before completion
NCT01701037 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT01701037 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01701037 about?
NCT01701037 is a clinical study titled "Dabrafenib Alone and in Combination With Trametinib Before Surgery in Treating Patients With Locally or Regionally Advanced Melanoma That Can Be Removed By Surgery". This phase II trial studies how well giving dabrafenib alone and in combination with trametinib before surgery works in treating patients with advanced melanoma that can be removed by surgery. Studying samples of tumor tissue in the laboratory from patients receiving dabrafenib and trametinib may he...
What is the current status of trial NCT01701037?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2013-01. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01701037?
The interventions under investigation include: laboratory biomarker analysis (OTHER), dabrafenib (DRUG), trametinib (DRUG).
Who is sponsoring clinical trial NCT01701037?
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 NCT01701037's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 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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