Metastatic Thyroid Gland Carcinoma Clinical Trial
Official title:
A Phase 1 Study of Dabrafenib in Combination With Lapatinib in BRAF Mutant Thyroid Cancer
This phase I trial studies the side effects and best dose of lapatinib when given together with dabrafenib in treating patients with thyroid cancer that cannot be removed by surgery and has not responded to previous treatment (refractory). Dabrafenib selectively binds to and blocks the activity of v-raf murine sarcoma viral oncogene homolog B (BRAF), which may block the growth of tumor cells which contain a mutated BRAF gene. Lapatinib reversibly blocks the process in which a phosphate group is added to a molecule (phosphorylation) of the epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 2 (ErbB2), and the mitogen-activated protein kinase 3 (Erk-1) and mitogen-activated protein kinase 1(Erk-2) and protein kinase B (AKT) kinases. It also blocks cyclin D protein levels in human tumor cell lines. Dabrafenib and lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVE: I. To determine the maximum tolerated dose of lapatinib that can be used in combination of dabrafenib. SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity. II. Evaluate potential mechanisms of primary resistance of BRAF mutant thyroid cancer to dabrafenib by performing pathway profiling of tumor biopsies before and while on therapy. III. Obtain preliminary data on the activity of the combination of lapatinib and dabrafenib in BRAF mutant thyroid cancer through imaging. OUTLINE: This is a dose-escalation study of lapatinib. Patients receive dabrafenib orally (PO) twice daily (BID) on days 1-28 of each cycle. After two weeks of single agent dabrafenib, patients also start receiving lapatinib PO once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo tumor biopsy, blood sample collection, echocardiography (ECHO) or multigated acquisition scan (MUGA), as well as positron emission tomography (PET), computed tomography (CT), or magnetic resonance imaging (MRI) during screening and on study. After completion of study treatment, patients are followed up for 4 weeks and then annually thereafter. ;
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