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Dabrafenib Alone and in Combination With Trametinib Before Surgery in Treating Patients With Locally or Regionally Advanced Melanoma That Can Be Removed By Surgery

NCT01701037 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-06-23

Study results available
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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.

Conditions

  • Recurrent Melanoma
  • Stage IIB Melanoma (Locally Advanced)
  • Stage IIC Melanoma (Locally Advanced)
  • Stage IIIA Melanoma
  • Stage IIIB Melanoma
  • Stage IIIC Melanoma
  • Stage IV Melanoma (Limited, Resectable)

Interventions

DRUG

dabrafenib

150 mg given PO

DRUG

trametinib

2 mg given PO

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

Principal Investigators

  • Mark Kelley · Vanderbilt-Ingram Cancer Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-02-28
Completion
2015-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01701037 on ClinicalTrials.gov