Clinical Trials Directory

Trials / Completed

CompletedNCT02259725

Regorafenib in Treating Patients With Advanced or Metastatic Neuroendocrine Tumors

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
3 (actual)
Sponsor
University of Southern California · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGregorafenibGiven PO
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2016-08-16
Primary completion
2020-08-20
Completion
2020-08-20
First posted
2014-10-08
Last updated
2021-12-15
Results posted
2021-12-15

Locations

5 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT02259725. Inclusion in this directory is not an endorsement.