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

This study is currently recruiting participants.
Verified May 2017 by Pan Yueyin, Anhui Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01963195
First Posted: October 16, 2013
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pan Yueyin, Anhui Medical University
  Purpose
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 Intervention Phase
NSCLC Drug: Icotinib Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pan Yueyin, Anhui Medical University:

Primary Outcome Measures:
  • safety and efficacy [ Time Frame: 2 years ]
    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.


Estimated Enrollment: 30
Study Start Date: February 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: high dose of Icotinib

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  4. ECOG 0-2 score
  5. at least 12 weeks of expected survival time
  6. 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
  7. 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01963195


Contacts
Contact: Hu Liu, MD 865512922987 drliuhu@gmail.com

Locations
China, Anhui
Dept. of Oncology,The First Affiliated Hospital of Anhui Medical Univesrsity Recruiting
Hefei, Anhui, China, 230032
Contact: Hu Liu, MD    865512922987    drliuhu@gmail.com   
Principal Investigator: Yueyin Pan, MD         
Sponsors and Collaborators
Anhui Medical University
Investigators
Principal Investigator: Yueyin Pan, MD Anhui Medical University
  More Information

Responsible Party: Pan Yueyin, Professor, Anhui Medical University
ClinicalTrials.gov Identifier: NCT01963195     History of Changes
Other Study ID Numbers: DEI-ADNSCLC
First Submitted: January 4, 2012
First Posted: October 16, 2013
Last Update Posted: May 8, 2017
Last Verified: May 2017

Keywords provided by Pan Yueyin, Anhui Medical University:
Adverse Reaction to Drug
Self Efficacy