Clinical Trials Directory

Trials / Completed

CompletedNCT04860700

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
27 (actual)
Sponsor
Peking Union Medical College Hospital · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGanlotinib hydrochloridePatients 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.

Timeline

Start date
2021-04-30
Primary completion
2023-10-17
Completion
2023-10-17
First posted
2021-04-27
Last updated
2024-06-12

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT04860700. Inclusion in this directory is not an endorsement.