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.
Name: Vemurafenib (All Groups)
Description: 960 mg by mouth 2 times a day 56 days prior to surgery (patients not planned for surgical resection will have a core biopsy at day 56.Type: DrugVemurafenib - (Presurgery)
Name: Vemurafenib (Post Surgery) - Group A + C
Description: Group A: 960 mg by mouth twice a day 2 weeks post-surgery. Restaged 8 weeks after resuming drug. If patients demonstrate either stable or regressing disease, they will continue on vemurafenib with restaging occurring every 8 weeks until they are no longer benefitting from the drug. Group C: Patients not scheduled for surgical resection undergo a CT scan and core biopsy at day 56. Vemurafenib 960 mg by mouth twice a day, continued unless there is evidence of progressive disease on day 56 CT scan. Patients restaged every 8 weeks and continue vemurafenib until no longer benefitting from the drug. Patients evaluated for resectability after each CT scan is performed. If patient is scheduled for resection, then patient will continue vemurafenib until surgery and will follow the same treatment schema as patients in Groups A and B.Type: DrugVemurafenib - (Presurgery) Vemurafenib (Post Surgery) - Group A Vemurafenib - Group C
Name: Post Surgery - Group B
Description: Patients who have had a complete surgical resection, and who do not have evidence of metastatic disease will discontinue vemurafenib after surgery. Patients restaged with CT neck 8 weeks after surgery.Type: OtherVemurafenib - (Presurgery)
Description: ERK phosphorylation and tumor size measured at baseline before first dose of Vemurafenib and again after 56 days of Vemurafenib. We will test whether correlation between percent change in ERK phosphorylation and percent change in tumor size is different from 0 with a t-test.
Measure: Percent Change in ERK (Extracellular-Signal-Regulated Kinase) Phosphorylation and Tumor Size Time: 56 daysDescription: Objective response rate defined as proportion of patients who have had a partial response (PR) or complete response (CR) after initiation of therapy with Vemurafenib, using RECIST 1.1. All patients who complete baseline and day 56 scans evaluable for this endpoint.
Measure: Objective Response Rate Time: 56 daysAllocation: Non-Randomized
Parallel Assignment
There is one SNP
4. BRAF V600E mutation detected in the primary tumor or the recurrent/persistent tumor. 5. Total bilirubin V600E ---