Spots Global Cancer Trial Database for Regorafenib in Treating Patients With Advanced or Metastatic Neuroendocrine Tumors

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Trial Identification

Brief Title: Regorafenib in Treating Patients With Advanced or Metastatic Neuroendocrine Tumors

Official Title: Phase II Study of Single Agent Regorafenib in Patients With Advanced/Metastatic Neuroendocrine Tumors

Study ID: NCT02259725

Conditions

Gastrinoma

Glucagonoma

Insulinoma

Metastatic Gastrointestinal Carcinoid Tumor

Pancreatic Polypeptide Tumor

Pulmonary Carcinoid Tumor

Recurrent Gastrointestinal Carcinoid Tumor

Recurrent Islet Cell Carcinoma

Somatostatinoma

Interventions

regorafenib

laboratory biomarker analysis

Study Description

Brief Summary: This phase II trial studies regorafenib in treating patients with neuroendocrine tumors that have spread from the primary site (place where it started) to other places in the body. Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Description: PRIMARY OBJECTIVES: I. To assess progression-free survival (PFS) in advanced/metastatic in patients with carcinoid or pancreatic islet cell tumors. SECONDARY OBJECTIVES: I. To assess overall survival and response rate in advanced/metastatic poor prognosis in patients with carcinoid or pancreatic islet cell tumors. II. To assess the toxicity of patients treated with regorafenib. III. To explore markers of angiogenesis as they relate to outcome in carcinoid and pancreatic islet cell tumors. OUTLINE: Patients receive regorafenib orally (PO) once daily (QD) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.