Neuroendocrine Neoplasm Clinical Trial
Official title:
A Phase II Study of Lenvatinib in Combination With Everolimus in Patients With Advanced Carcinoid Tumors
This phase II trial studies how well lenvatinib and everolimus work in treating patients with carcinoid tumors that have spread to other places in the body (advanced) and cannot be removed by surgery (unresectable). Lenvatinib and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVE: I. To estimate the Response Evaluation Criteria in Solid Tumors (RECIST) (per version 1.1) objective response rate of lenvatinib in combination with everolimus among patients with advanced carcinoid tumors. SECONDARY OBJECTIVES: I. To evaluate the progression free survival duration of lenvatinib in combination with everolimus among patients with advanced carcinoids. II. To evaluate the safety and tolerability of lenvatinib in combination with everolimus among patients with advanced carcinoid tumors. EXPLORATORY OBJECTIVES: I. To determine clinic benefit rate at 6 months (defined as complete response plus partial response plus stable disease) with lenvatinib + everolimus among patients with advanced carcinoid tumors. II. To determine early CgA and neuron-specific enolase (NSE) response rates. OUTLINE: Patients receive lenvatinib orally (PO) daily and everolimus PO daily on days 1-28. Treatments repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days. ;
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