CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 93 enrolled
Drug / intervention
sorafenib tosylatedrug
Likely dose
Sorafenib 400 mg orallyAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed metastatic neuroendocrine tumor (carcinoid or islet cell carcinoma)
  • ✓Well-differentiated histology only
  • ✓Measurable disease present
  • ✓ECOG performance status 0-2
Key exclusion· 8
  • ✕Brain metastases (any)
  • ✕Anaplastic or high-grade neuroendocrine tumor histology
  • ✕Thyroid carcinoma, thymoma, or pheochromocytoma/paraganglioma
  • ✕Gastrointestinal disease preventing oral medication absorption

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00131911
NCT00131911Phase 2Completed
CompareCT.gov

A Phase II Trial of Bay 43-9006 in Progressive Metastatic Neuroendocrine Tumors

National Cancer Institute (NCI)·interventional·Posted Aug 19, 2005·Updated Nov 17, 2014

In Brief

A Phase 2 clinical trial evaluating sorafenib tosylate for Gastrinoma and 9 related conditions. Completed, enrolled 93 participants across 1 site.

Detailed Summary

This phase II trial is studying how well sorafenib tosylate works in treating patients with progressive metastatic neuroendocrine tumors. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrinoma, Glucagonoma, Insulinoma, Metastatic Gastrointestinal Carcinoid Tumor, Neuroendocrine Tumor, Pancreatic Polypeptide Tumor, Recurrent Gastrointestinal Carcinoid Tumor, Recurrent Islet Cell Carcinoma, Somatostatinoma, WDHA Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 19, 2005
Enrollment StartJun 1, 2005
Primary CompletionOct 1, 2010
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 20.9 years ago

Interventions

sorafenib tosylatedrug

400 mg given orally