Study to Evaluate the Effects of Cabozantinib in Patients With Unresectable Metastatic Pheochromocytomas and Paragangliomas
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|ClinicalTrials.gov Identifier: NCT02302833|
Recruitment Status : Recruiting
First Posted : November 27, 2014
Last Update Posted : April 20, 2018
The goal of this clinical research study is to learn if cabozantinib can help to control advanced or metastatic pheochromocytoma or paraganglioma. The safety of this drug will also be studied.
This is an investigational study. Cabozantinib is FDA-approved and commercially available for the treatment of metastatic medullary thyroid cancer. It is investigational to give cabozantinib to patients with pheochromocytoma or paraganglioma. The study doctor can explain how the study drug is designed to work.
Up to 22 participants will be enrolled in this study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: Cabozantinib Behavioral: Questionnaire||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study to Evaluate the Effects of Cabozantinib in Patients With Unresectable Metastatic Pheochromocytomas and Paragangliomas|
|Actual Study Start Date :||February 2015|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2021|
Participants take Cabozantinib by mouth at a dose of 60 mg once daily. Questionnaire completion regarding symptoms completed at baseline, 4 days before starting Cabozantinib, and weekly while taking the drug.
60 mg by mouth once daily.
Questionnaire completion regarding symptoms completed at baseline, 4 days before starting Cabozantinib, and weekly while taking the drug.
Other Name: Survey
- Overall Response Rate of Cabozantinib in Participants with Malignant Pheochromocytomas and Paragangliomas [ Time Frame: 8 weeks ]Primary endpoint is to estimate best overall response rate by RECIST 1.1 in participants with measurable disease determined by CT/MRI. Tumor response assessed at a frequency of 8 weeks. In participants with bone metastases, an FDG-PET scan obtained every 8 weeks.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302833
|Contact: Camilo Jimenez, MD||713-792-2841|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Camilo Jimenez, MD||M.D. Anderson Cancer Center|