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NCT01611675 · ClinicalTrials.gov registry record · Phase 1
Leflunomide+Vemurafenib in V600 Mutant Met. Melanoma
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT01611675: Clinical Trial Phase 1 study, sponsored by Massachusetts General Hospital.
NCT01611675 is a Phase 1 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01611675, a Phase 1 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This research study was intended to be a Phase I/II clinical trial, but the trial was terminated before the phase 1 portion was completed. Phase I clinical trials test the safety of an investigational combination of drugs. Phase I studies also try to define the appropriate dose of the investigational drug combination to use for the Phase II portion of the study, which will enroll more participants and continue to study the effects of the drug and the safest dose. "Investigational" means that the combination of vemurafenib and leflunomide is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved this drug combination for your type of cancer. Genes are a specific part of your cell materials which send code messages to determine what the investigators bodies look like, such as eye color, and instruct cells to control growth and development of the body. Researchers have found that a large number of melanoma cells have mutations in the BRAF gene. Normally, the BRAF gene helps to control how cells grow. Mutations in the BRAF gene may disrupt this control and allow cells in the skin to change into cancer cells, in which case, the cells keep dividing and growing out of control. Specifically, it has been shown that vemurafenib blocks the effects of these mutations in the BRAF gene, and, as a result, may help to prevent cancer growth. The FDA has approved vemurafenib for use in patients with BRAF mutation positive melanoma that is unable to be removed by surgery (unresectable) or that has spread (metastatic). Leflunomide is in a class of medications called disease-modifying antirheumatic drugs (DMARDs). It is FDA approved for the treatment of rheumatoid arthritis and it is believed to decrease inflammation in that setting. However it is not approved for treatment of melanoma. The researchers of this study believe this agent may help prevent cancer growth as well as enhance the properties of drugs that
Interventions
- DRUG Vemurafenib
- DRUG Leflunomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2012-07 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01611675
The ClinicalTrials.gov registry entry for NCT01611675 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vemurafenib is the first listed.
NCT01611675 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01611675 about?
NCT01611675 is a clinical study titled "Leflunomide+Vemurafenib in V600 Mutant Met. Melanoma". This research study was intended to be a Phase I/II clinical trial, but the trial was terminated before the phase 1 portion was completed. Phase I clinical trials test the safety of an investigational combination of drugs. Phase I studies also try to define the appropriate dose of the investigationa...
What is the current status of trial NCT01611675?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2012-07. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01611675?
The interventions under investigation include: Vemurafenib (DRUG), Leflunomide (DRUG).
Who is sponsoring clinical trial NCT01611675?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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