NCT02328261

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2014

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

December 31, 2014

Status Verified

November 1, 2014

Enrollment Period

1.9 years

First QC Date

November 24, 2014

Last Update Submit

December 26, 2014

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Disease control rate(DCR)

    At least 8 weeks

Secondary Outcomes (1)

  • Progression-free survival

    At least 8 weeks

Study Arms (1)

Icotinib

EXPERIMENTAL

Icotinib (125 mg tablet) is orally administered three times daily

Drug: Icotinib

Interventions

IcotinibDRUG

Icotinib (125 mg tablet) is orally administered three times daily until disease progression or unaccepted toxicity.

Also known as: Conmana
Icotinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

icotinib

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Xiaohua Hu, MD

    The first affliated hospital of Guangxi medical university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2014

First Posted

December 31, 2014

Study Start

November 1, 2014

Primary Completion

October 1, 2016

Study Completion

April 1, 2017

Last Updated

December 31, 2014

Record last verified: 2014-11