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

Sponsor
Anhui Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01963195
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
69.9
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

  • 1:to evaluate the efficacy correlation between the tyrosine kinase inhibitor (TKI) drugs and high-dose Icotonib group in advanced NSCLC patients with high -dose Icotinib going on after the routine TKI therapy

  • 2 to evaluate the efficacy correlation between different high-dose group in advanced NSCLC patients with high -dose Icotinib going on after the routine TKI therapy

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open, Single Center Trial to Evaluate the Efficacy and Safety of Dose Escalation of Icotinib in Advanced NSCLC Patients After TKI Therapy
Study Start Date :
Feb 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Icotinib

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
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
Other Names:
  • high dose of Icotinib

    		•

    Outcome Measures

    Primary Outcome Measures

    1. safety and efficacy [2 years]

      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). The safety of high dosage of Icotinib will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. NSCLC patients were confirmed by histology or cytology

    2. 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.

    3. at least one measureable lesion accord to RECIST 1.1 criteria and the lesion accepted no radiotherapy.

    • 1 at least one measureable lesion .if only one measureable lesion, the biological nature must be confirmed by cytology or histology.

    • 2 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.

    1. ECOG 0-2 score

    2. at least 12 weeks of expected survival time

    3. 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

    4. understand and sign a written informed consent voluntarily.

    Exclusion Criteria:

    If the subject meet any of the following exclusion criteria ,he is no eligible to participate in this study,

    1. Before enrollment in this trial have used Erbitux, Herceptin and carried out anti-cancer therapy.

    2. use of phenytoin, carbamazepine, rifampicin, phenobarbital or St. John's Wort when take this trial

    3. severe allergies to Icotinib

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept. of Oncology,The First Affiliated Hospital of Anhui Medical Univesrsity Hefei Anhui China 230032

    Sponsors and Collaborators

    • Anhui Medical University

    Investigators

    • Principal Investigator: Yueyin Pan, MD, Anhui Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pan Yueyin, Professor, Anhui Medical University
    ClinicalTrials.gov Identifier:
    NCT01963195
    Other Study ID Numbers:
    • DEI-ADNSCLC
    First Posted:
    Oct 16, 2013
    Last Update Posted:
    May 8, 2017
    Last Verified:
    May 1, 2017
    Keywords provided by Pan Yueyin, Professor, Anhui Medical University
    Adverse Reaction to Drug
    Self Efficacy

    Study Results

    No Results Posted as of May 8, 2017