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Clinical Trials/NCT03906058
NCT03906058
Completed
Phase 2

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

Sun Yat-sen University1 site in 1 country39 target enrollmentApril 29, 2019
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ConditionsNasopharyngeal Carcinoma
InterventionsAnlotinib
DrugsAnlotinib

Overview

Phase
Phase 2
Intervention
Anlotinib
Conditions
Nasopharyngeal Carcinoma
Sponsor
Sun Yat-sen University
Enrollment
39
Locations
1
Primary Endpoint
disease control rate
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief 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

Registry
clinicaltrials.gov
Start Date
April 29, 2019
End Date
April 30, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Qingqing Cai

Chief physician

Sun Yat-sen University

Eligibility Criteria

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.

Arms & Interventions

Anlotinib

Intervention: Anlotinib

Outcomes

Primary Outcomes

disease control rate

Time Frame: 30 months

disease control rate

Secondary Outcomes

  • duration of response(30 months)
  • overall survival(30 months)
  • progression-free survival(30 months)
  • overall response rate(30 months)

Study Sites (1)

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