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NCT03906058 Clinical Trial

Anlotinib in Recurrent or Metastatic Nasopharyngeal Carcinoma Patients After Failure of no Less Than Second-line Therapy

Nasopharyngeal Carcinoma Clinical Trial

Official title:
Open-Label, Phase Ⅱ Study of Anlotinib Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma After Failure of no Less Than Second-line Chemotherapy or Targeted Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03906058
Other study ID # B2018-167
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 29, 2019
Est. completion date April 30, 2022

Study information
Verified date October 2023
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this single arm, phase Ⅱ clinical trial is to evaluate the efficacy and safety of Anlotinib Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma after failure of no less than second-line chemotherapy or targeted therapy

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date April 30, 2022
Est. primary completion date February 27, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - biopsy proved nasopharyngeal carcinoma; - stage IVB according to American Joint Committee on Cancer(AJCC) edition VIII, or recurrent disease after chemotherapy and/or radiotherapy; - 18 years or older; without other malignancy; - proper functioning of the major organs. Exclusion Criteria: - allergic to anlotinib; - female within gestation period or lactation; - patients received drug of other clinical trial within 4 weeks.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Anlotinib
All patients enrolled in the study will accept anlotinib treatment as a palliative treatment .

Locations
Country Name City State
China Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary disease control rate disease control rate 30 months
Secondary overall response rate overall response rate 30 months
Secondary progression-free survival progression-free survival 30 months
Secondary overall survival overall survival 30 months
Secondary duration of response duration of response 30 months
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