A Phase II Study of Icotinib in Treating Patients With Ad... | NCT02328261

Studies
A Phase II Study of Icotinib in Treating Patients With Advanced Nasopharyngeal Carcinoma

NCT02328261

Sponsor

Betta Pharmaceuticals Co., Ltd.

Status

Unknown status

Last Update Posted

Dec 31, 2014Estimated

Enrollment

66Estimated

Phase

Phase 2

Conditions

Nasopharyngeal Carcinoma

Interventions

Icotinib

Countries

Not provided

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

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Oct 2016Estimated

Completion Date

Apr 2017Estimated

First Submitted Date

Nov 24, 2014

First Submission Date that Met QC Criteria

Dec 26, 2014

First Posted Date

Dec 31, 2014Estimated

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

Dec 26, 2014

Last Update Posted Date

Dec 31, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This is a phase 2 study to evaluate the efficacy of single-agent icotinib in patients with advanced nasopharyngeal carcinoma.

Detailed Description

This phase 2 study is aimed to evaluate the efficacy of single-agent icotinib in patients with pretreated, advanced nasopharyngeal carcinoma. The primary endpoint is disease control rate (DCR).

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

66Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Icotinib	Experimental	Icotinib (125 mg tablet) is orally administered three times daily	Drug: Icotinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Icotinib	Drug	Icotinib (125 mg tablet) is orally administered three times daily until disease progression or unaccepted toxicity.	Icotinib

Measure	Description	Time Frame
Disease control rate(DCR)		At least 8 weeks

Measure	Description	Time Frame
Progression-free survival		At least 8 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed advanced NPC
Patients must be platinum-resistant defined as recurrence or progression of disease <6 months since previous treatment with a platinum based treatment regimen.
Measurable disease per RECIST
Adequate organ and marrow function
Capable of understanding and complying with the protocol, and written informed consent

Exclusion Criteria:

Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR
Patients must not be receiving any other investigational agents
Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection
Women who are pregnant or breast-feeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiaohua Hu, MD	The first affliated hospital of Guangxi medical university	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000077274	Nasopharyngeal Carcinoma

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C531470	icotinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided