Evaluation of the High Dose of Icotinib in Advanced Lung Cancer Patients After Failure of Target Therapy

NCT01963195 | Unknown Phase 2 DMC

• 1 other identifier: DEI-ADNSCLC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of dose escalation of Icotinib in advanced non small cell lung cancer (NSCLC) patients after the therapy of Icotinib, Iressa and Tarceva.

Conditions

NSCLC

Keywords

Adverse Reaction to Drug; Self Efficacy

Outcome Measures

Primary Outcomes (1)

• safety and efficacy

  1. The efficacy of dose escalation of Icotinib in advanced NSCLC patients after failure of TKI (Icotinib 125mg po tid. Iressa 250mg po qd. Tarceva 150mg po qd) therapy will be evaluated according to the revised RECIST 1.1 (Response Evaluation Criteria In Solid Tumors). 2. The safety of high dosage of Icotinib will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

  2 years

Study Arms (1)

Icotinib

EXPERIMENTAL

Patients can accept the treatment with Icotinib (250/375/500mg tid) until disease progression or unacceptable toxicity occurred. The overall study period takes about 24 months

Drug: Icotinib

Interventions

Icotinib DRUG

Patients can accept the treatment with Icotinib (250/375/500mg tid) until disease progression or unacceptable toxicities occurred. The overall study period takes about 24 months

Also known as: high dose of Icotinib

Icotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NSCLC patients were confirmed by histology or cytology
• The time interval must be over 4 weeks from previous chemotherapy to registration to participate in this experiment if he or she received chemotherapy,and also have any toxicity to recover.
• at least one measureable lesion accord to RECIST 1.1 criteria and the lesion accepted no radiotherapy.
• at least one measureable lesion .if only one measureable lesion, the biological nature must be confirmed by cytology or histology.
• a single diameter of lesion could be measured by at least one of the following methods: Chest or abdominal computed tomography(CT)or magnetic resonance imaging(MRI),conventional methods of diameter at least 20mm diameter spiral CT OR at least 10mm.
• ECOG 0-2 score
• at least 12 weeks of expected survival time
• Women of childbearing age must have a pregnancy test 7 days before treatment and the result were negative ,men of childbearing age: surgical sterilization or treatment during and after the end of three months to take contraceptive measures
• understand and sign a written informed consent voluntarily.

You may not qualify if:

• Before enrollment in this trial have used Erbitux, Herceptin and carried out anti-cancer therapy.
• use of phenytoin, carbamazepine, rifampicin, phenobarbital or St. John's Wort when take this trial
• severe allergies to Icotinib

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Dept. of Oncology,The First Affiliated Hospital of Anhui Medical Univesrsity

Hefei, Anhui, 230032, China

RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

icotinib

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Yueyin Pan, MD

  Anhui Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hu Liu, MD

CONTACT

865512922987; drliuhu@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: October 16, 2013
• Study Start: February 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

CN (1)