OncoMatch/Clinical Trials/NCT03975231
Dabrafenib, Trametinib, and IMRT in Treating Patients With BRAF Mutated Anaplastic Thyroid Cancer
Is NCT03975231 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Dabrafenib and Trametinib for braf np_004324.2:p.v600e.
Treatment: Dabrafenib · Trametinib — This trial studies how well dabrafenib, trametinib, and intensity modulated radiation therapy (IMRT) work together in treating patients with BRAF mutated anaplastic thyroid cancer. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving dabrafenib, trametinib, and IMRT together may kill more tumor cells.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: BRAF v600e
Required: BRAF v600k
Disease stage
Excluded: Stage IVA
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: external beam radiotherapy
Exception: to neck or chest for cancer that would result in overlap of radiation therapy fields
Patients who have had external beam radiotherapy to neck or chest for cancer that would result in overlap of radiation therapy fields
Cannot have received: cytotoxic chemotherapy
Exception: within 2 weeks prior to study treatment initiation
Patients who have had cytotoxic chemotherapy...within 2 weeks prior to study treatment initiation
Cannot have received: stereotactic brain radiation
Exception: within 2 weeks prior to study treatment initiation
Patients who have had...stereotactic brain radiation...within 2 weeks prior to study treatment initiation
Cannot have received: external beam radiation
Exception: within 2 weeks prior to study treatment initiation
Patients who have had...external beam radiation within 2 weeks prior to study treatment initiation
Cannot have received: oral multikinase inhibitor
Exception: within 1 week prior to study treatment initiation
Patients who have had oral multikinase inhibitors within 1 week prior to study treatment initiation
Cannot have received: BRAF inhibitor
Exception: previous treatment with sorafenib is permitted
Patients previously treated with potent BRAF inhibitor or MEK inhibitor. Previous treatment with sorafenib is permitted.
Cannot have received: MEK inhibitor
Exception: previous treatment with sorafenib is permitted
Patients previously treated with potent BRAF inhibitor or MEK inhibitor. Previous treatment with sorafenib is permitted.
Lab requirements
Blood counts
Absolute neutrophil count > 1,000/mcL; Hemoglobin >= 9.0 g/dl; Platelets > 75,000/mcL
Kidney function
Serum creatinine < 1.5 x institutional upper limit of normal
Liver function
Total bilirubin < 1.5 x institutional upper limit of normal (unless due to Gilbert’s disease); AST/ALT < 2.5 x institutional upper limit of normal
Cardiac function
Corrected QT (QTc) interval < 480 msecs (< 500 msec for subjects with Bundle Branch Block); NYHA class II, III, or IV heart failure excluded
Absolute neutrophil count > 1,000/mcL. Hemoglobin >= 9.0 g/dl. Platelets > 75,000/mcL. Total bilirubin < 1.5 x institutional upper limit of normal (unless due to Gilbert’s disease). AST/ALT < 2.5 x institutional upper limit of normal. Serum creatinine < 1.5 x institutional upper limit of normal. Corrected QT (QTc) interval greater than or equal to 480 msecs (>= 500 msec for subjects with Bundle Branch Block). Patients with class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
- Univ of Texas-M.D. Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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