NCT01466036

Cabozantinib in Advanced Pancreatic Neuroendocrine and Carcinoid Tumors

An Open-Label, Phase II Study of Cabozantinib (XL184) in Advanced Pancreatic Neuroendocrine and Carcinoid Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cabozantinib works by blocking the growth of new blood vessels that feed a tumor. In addition to blocking the formation of new blood cells in tumors, cabozantinib also blocks pathways that may be responsible for allowing cancers cells to become resistant to other "anti-angiogenic" drugs. Cabozantinib has been studied or is being study in research studies as a possible treatment for various types of cancer, including prostate cancer, brain cancer, thyroid cancer, lung cancer, and kidney cancer. In this research study, the investigators wish to learn if cabozantinib is effective in treating patients with pancreatic neuroendocrine and carcinoid tumors.

Detailed description

Subjects will take cabozantinib orally, once per day, in cycles of 28 days. During each cycle subjects will have the following procedures: * Physical examination, including measurement of weight and vital signs * Questions regarding any side effects * Blood sample (about 1 tablespoon) for routine laboratory tests of blood cell counts, blood chemistries, organ function and blood clotting * Blood sample (about 4 tablespoons) for research test to measure biomarkers to assess the response to study drug * Urine sample for routine urine tests to monitor health On Day 15 (beginning of week 3) during the first 3 cycles: * Physical examination, including measurement of weight and vital signs * Questions regarding any side effects * Blood sample (about 1 tablespoon) for routine laboratory tests of blood cell counts, blood chemistries, organ function and blood clotting * Blood sample (about 4 tablespoons) for research test to measure biomarkers to assess the response to study drug Subjects will receive a CT scan or MRI every two cycles (every two months) to evaluate disease.

Conditions

• Carcinoid Tumor
• Pancreatic Neuroendocrine Tumor

Interventions

Type	Name	Description
DRUG	Cabozantinib	60 mg QD orally in cycles of 28 days

Timeline

• Start date: 2012-07-01
• Primary completion: 2021-08-01
• Completion: 2023-12-01
• First posted: 2011-11-07
• Last updated: 2024-03-05
• Results posted: 2023-07-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study