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ACTIVE NOT RECRUITING

NCT01709292

PHASE2

Vemurafenib Neoadjuvant Trial in Locally Advanced Thyroid Cancer

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

Official title: Pharmacodynamic Study of Vemurafenib in the Neoadjuvant Setting in Patients With Locally Advanced Thyroid Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2012-11-07

Completion Date

2026-09-30

Last Updated

2025-10-27

Healthy Volunteers

Conditions

Thyroid Cancer

Interventions

DRUG

Vemurafenib (All Groups)

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.

DRUG

Vemurafenib (Post Surgery) - Group A + C

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.

OTHER

Post Surgery - Group B

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.

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 \</= 1.5 x upper limit of normal (ULN). Patients with Gilbert's syndrome are excluded from this requirement. Aspartate transaminase (serum glutamic oxaloacetic transaminase) / alanine transaminase (serum glutamic pyruvic transaminase) (AST\[SGOT\]/ALT\[SGPT\]) \</= 2.5 x ULN, (5 x ULN for patients with concurrent liver metastases). Serum creatinine \</= within 1.5 x ULN. Absolute neutrophil count (ANC) \>/= 1.0 x 10\^9/L; platelets \>/= 100 x 10\^9/L, HgB\>9 mg/dL 6. Antiangiogenic therapy, specifically vascular endothelial growth factor (VEGF) and VEGF receptor (VEGFR) inhibitors, can interfere with wound healing and therefore will only be allowed if the agent has been discontinued for at least 14 days prior to day 1. Group C patients must be naïve to therapies which target mitogen-activated protein kinase (MAPK). 7. Ability to swallow pills. 8. Eastern Cooperative Oncology Group (ECOG) performance status \</= 2 9. Age \>/= 18 10. Ability to provide consent. Exclusion Criteria: 1. Histological diagnosis other than PTC. Patients with anaplastic tumors are not eligible. However, patients whose tumors contain areas of un-differentiated or dedifferentiated histology may enroll provided the original diagnosis was clearly PTC, and the tumor histology remains predominantly papillary at enrollment. 2. Refractory nausea and vomiting, malabsorption, or significant bowel resection that would preclude adequate absorption. 3. Known hepatitis B or C virus (HBV or HCV) infection, unless the patient has been cleared for chemotherapy from experts on viral hepatitis (infectious disease specialists or hepatologists). 4. Pregnant or lactating women. All pre-menopausal women being screened must have a negative serum pregnancy test within 14 days prior to commencement of dosing. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for \>/= 1 year 5. Untreated brain metastases. 6. Chemotherapy or targeted therapy within 14 days or 5 half-lives (whichever is longer) prior to the start of study treatment. 7. Patients with history of long QT syndrome, uncorrectable electrolyte abnormalities, or QTc\>500msec. 8. History of significant cardiac disease or uncontrolled arrhythmias.

Locations (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, United States