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NCT00631618 · ClinicalTrials.gov registry record · Phase 2
Clinical Trial of Sutent to Treat Metastatic Melanoma
A Phase 2 study, sponsored by California Pacific Medical Center Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT00631618 is a Phase 2 study that has completed, run by California Pacific Medical Center Research Institute. The registered enrollment target is 12 participants.
The verdict
NCT00631618, a Phase 2 study, has completed, sponsored by California Pacific Medical Center Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate whether an investigational drug called sunitinib malate is safe and effective in treating metastatic melanoma in patients with KIT mutations. KIT is a gene that "codes for" (contains the genetic code that the body uses to make) a protein on the surface of cells in your body that is important in cell growth and cell division. The KIT protein seems to play a role in abnormal cell growth seen in acute leukemia, germ cell tumors, gastrointestinal stromal tumors (GIST), and certain melanomas. Melanomas that arise on acral skin (palms, soles, nail beds), mucosal membranes, and chronically sun damaged skin have recently been found to frequently contain mutations or increased copy numbers of the KIT gene. Your tumor tissue has previously been tested and has been found to contain abnormalities in the KIT gene. Sunitinib malate is drug that has been shown to inhibit the activity of the KIT protein. The FDA approved sunitinib in 2006 for patients with GIST. It has been shown that sunitinib malate works in these patients because of its activity against the KIT protein. The FDA also approved Sunitinib malate in 2006 for the treatment of metastatic kidney cancer, where its effectiveness is probably due to its ability to block a different set of proteins. Sunitinib malate has not been approved by the FDA for the treatment of metastatic melanoma.
Interventions
- DRUG Sutent (sunitinib)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2007-09 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00631618
The ClinicalTrials.gov registry entry for NCT00631618 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is California Pacific Medical Center Research Institute, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sutent (sunitinib) is the first listed.
NCT00631618 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00631618 about?
NCT00631618 is a clinical study titled "Clinical Trial of Sutent to Treat Metastatic Melanoma". The purpose of this study is to investigate whether an investigational drug called sunitinib malate is safe and effective in treating metastatic melanoma in patients with KIT mutations. KIT is a gene that "codes for" (contains the genetic code that the body uses to make) a protein on the surface of...
What is the current status of trial NCT00631618?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2007-09. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00631618?
The interventions under investigation include: Sutent (sunitinib) (DRUG).
Who is sponsoring clinical trial NCT00631618?
This trial is sponsored by California Pacific Medical Center Research Institute, which has 29 total clinical trials registered on ClinicalTrials.gov.
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