The Efficacy and Safety of Anlotinib in Patients With Metastatic Pheochromocytoma or Paraganglioma

Malignant Paraganglioma Clinical Trial

Official title: A Phase 2 Study of Anlotinib in Patients With Metastatic Pheochromocytoma or Paraganglioma

Status Completed

Clinical Trial Summary

This phase II trial studies how well anlotinib hydrochloride works in treating patients with metastatic pheochromocytoma or paraganglioma. Anlotinib hydrochloride 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.

Clinical Trial Description

PRIMARY OBJECTIVES:

To determine the anti-tumor activity of anlotinib hydrochloride (Objective Response rate,ORR) in patients with metastatic pheochromocytomas or paragangliomas.

SECONDARY OBJECTIVES:

I. To assess safety profile of anlotinib. II. To assess progression-free survival time. III. To assess disease control rate.

OUTLINE:

Patients receive anlotinib hydrochloride 12mg orally once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients undergo urine and blood sample collection, imaging examinations at baseline and periodically during study.

After completion of study therapy, patients are followed up every 3-6 months. ;

Related Conditions & MeSH terms

• Malignant Adrenal Gland Pheochromocytoma
• Malignant Paraganglioma
• Paraganglioma
• Pheochromocytoma

• NCT number: NCT04860700
• Study type: Interventional
• Source: Peking Union Medical College Hospital
• Status: Completed
• Phase: Phase 2
• Start date: April 30, 2021
• Completion date: October 17, 2023