Anlotinib in Recurrent or Metastatic Nasopharyngeal Carci... | NCT03906058

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

NCT03906058

Sponsor

Sun Yat-sen University

Status

Completed

Last Update Posted

Oct 25, 2023Actual

Enrollment

39Actual

Phase

Phase 2

Conditions

Nasopharyngeal Carcinoma

Interventions

Anlotinib

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 29, 2019Actual

Primary Completion Date

Feb 27, 2021Actual

Completion Date

Apr 30, 2022Actual

First Submitted Date

Apr 5, 2019

First Submission Date that Met QC Criteria

Apr 5, 2019

First Posted Date

Apr 8, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2023

Last Update Posted Date

Oct 25, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anlotinib	Experimental		Drug: Anlotinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anlotinib	Drug	All patients enrolled in the study will accept anlotinib treatment as a palliative treatment .	Anlotinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
disease control rate	disease control rate	30 months

Secondary Outcomes

Measure	Description	Time Frame
overall response rate	overall response rate	30 months
progression-free survival	progression-free survival	30 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University		Guangzhou	Guangdong	510000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37936166	Derived	Fang Y, Su N, Zou Q, Cao Y, Xia Y, Tang L, Tian X, Liu P, Cai Q. Anlotinib as a third-line or further treatment for recurrent or metastatic nasopharyngeal carcinoma: a single-arm, phase 2 clinical trial. BMC Med. 2023 Nov 7;21(1):423. doi: 10.1186/s12916-023-03140-x.

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms