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NCT02196181 · ClinicalTrials.gov registry record · Phase 2
Testing Two Different Treatment Schedules of Dabrafenib and Trametinib for Skin Cancer Which Has Spread
A Phase 2 study of Unresectable Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 280
- Enrollment target
- 20
- Study locations
NCT02196181 is a Phase 2 study of Unresectable Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 280 participants, above the 130-participant average among 24 other Unresectable Melanoma trials with a reported enrollment target (115% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT02196181, a Phase 2 study of Unresectable Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 280 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial compares the effect of dabrafenib and trametinib given continuously to given with a break in treatment (intermittent) in treating patients with stage III-IV melanoma that cannot be removed by surgery and contains a B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutation. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving dabrafenib and trametinib with intermittent dosing may be as effect as when given continuously in treating patients with stage III-IV melanoma with a BRAF mutation that cannot be removed by surgery.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Echocardiography Test
- PROCEDURE Multigated Acquisition Scan
- DRUG Dabrafenib Mesylate
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Regional Hospital - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- John L McClellan Memorial Veterans Hospital - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
- Highlands Oncology Group - Rogers - Rogers
Arizona
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
- Onvida Health Yuma Medical Center - Yuma
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2014-09-19 |
| Est. Completion | 2027-03-15 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02196181
The ClinicalTrials.gov registry entry for NCT02196181 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 130-participant average among 24 other Unresectable Melanoma trials with a reported enrollment target (115% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Unresectable Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT02196181 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Alaska, Arkansas, Arizona.
Frequently Asked Questions
What is clinical trial NCT02196181 about?
NCT02196181 is a clinical study titled "Testing Two Different Treatment Schedules of Dabrafenib and Trametinib for Skin Cancer Which Has Spread". This phase II trial compares the effect of dabrafenib and trametinib given continuously to given with a break in treatment (intermittent) in treating patients with stage III-IV melanoma that cannot be removed by surgery and contains a B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutation. Da...
What is the current status of trial NCT02196181?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 280 participants. The study started on 2014-09-19. Estimated completion is 2027-03-15.
What conditions does trial NCT02196181 study?
This clinical trial studies the following conditions: Unresectable Melanoma, Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage III Cutaneous Melanoma AJCC v7.
What interventions are being tested in trial NCT02196181?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Echocardiography Test (PROCEDURE), Multigated Acquisition Scan (PROCEDURE), Dabrafenib Mesylate (DRUG).
Who is sponsoring clinical trial NCT02196181?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02196181 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Unresectable Melanoma
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Stage IV Cutaneous Melanoma AJCC v6 and v7
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Alabama
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