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Active Not Recruiting
NCT01709292
Vemurafenib Neoadjuvant Trial in Locally Advanced Thyroid Cancer
Conditions: Thyroid Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 24
Sponsor: M.D. Anderson Cancer Center
Location: University of Texas MD Anderson Cancer Center Houston Texas
Summary
The goal of this clinical research study is to learn about how vemurafenib may affect certain biomarkers in patients with PTC. Biomarkers are in the blood/tissue and may be related to your reaction to the study drug. The safety of this drug will also be studied.
Vemurafenib is designed to block the BRAF gene mutation. This mutation causes cancer and cancer growth. By blocking this mutation, the drug may kill the cancer cells with the mutation and/or stop the tumor from growing.
Eligibility Criteria
Inclusion Criteria:
1. Primary papillary thyroid cancer (PTC), which appears to be stage T3 or T4 on imaging or with macroscopic lymph node involvement AND requires surgical resection.
2. Persistent or locally recurrent PTC with macroscopic lymph node involvement which requires surgical resection.
3. Patients deemed inoperable (no scheduled surgery) are eligible for this trial, as they could be surgical candidates after treatment with vemurafenib. Inoperable patients must be naïve to therapies targeting the MAPK pathway.
4. BRAF V600E mutation detected in the primary tumor or the recurrent/persistent tumor.
5. Total bilirubin \
Source: ClinicalTrials.gov (NCT01709292). StuddyBuddy aggregates publicly available trial information.