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NCT02231775 · ClinicalTrials.gov registry record · Phase 2
Dabrafenib and Trametinib Before and After Surgery in Treating Patients With Stage IIIB-C Melanoma With BRAF V600 Mutation
A Phase 2 study of Stage IIIC Cutaneous Melanoma AJCC v7 and Stage IIIB Cutaneous Melanoma AJCC v7, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT02231775 is a Phase 2 study of Stage IIIC Cutaneous Melanoma AJCC v7 and Stage IIIB Cutaneous Melanoma AJCC v7 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 58 participants, below the 204-participant average among 12 other Stage IIIC Cutaneous Melanoma AJCC v7 trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02231775, a Phase 2 study of Stage IIIC Cutaneous Melanoma AJCC v7 and Stage IIIB Cutaneous Melanoma AJCC v7, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single arm phase II trial focused on how dabrafenib and trametinib before and after surgery works in treating patients with stage IIIB-C melanoma that has a specific mutation in the BRAF gene. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving dabrafenib and trametinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving dabrafenib and trametinib after surgery may kill any remaining tumor cells.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- PROCEDURE Therapeutic Conventional Surgery
- DRUG Trametinib
- DRUG Dabrafenib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2014-10-22 |
| Est. Completion | 2027-04-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02231775
The ClinicalTrials.gov registry entry for NCT02231775 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 204-participant average among 12 other Stage IIIC Cutaneous Melanoma AJCC v7 trials with a reported enrollment target (72% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Stage IIIC Cutaneous Melanoma AJCC v7 appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02231775 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT02231775 about?
NCT02231775 is a clinical study titled "Dabrafenib and Trametinib Before and After Surgery in Treating Patients With Stage IIIB-C Melanoma With BRAF V600 Mutation". This is a single arm phase II trial focused on how dabrafenib and trametinib before and after surgery works in treating patients with stage IIIB-C melanoma that has a specific mutation in the BRAF gene. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes need...
What is the current status of trial NCT02231775?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2014-10-22. Estimated completion is 2027-04-01.
What conditions does trial NCT02231775 study?
This clinical trial studies the following conditions: Stage IIIC Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7.
What interventions are being tested in trial NCT02231775?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Therapeutic Conventional Surgery (PROCEDURE), Trametinib (DRUG), Dabrafenib (DRUG).
Who is sponsoring clinical trial NCT02231775?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02231775 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Stage IIIC Cutaneous Melanoma AJCC v7
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Stage IIIB Cutaneous Melanoma AJCC v7
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