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First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients

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ClinicalTrials.gov Identifier: NCT01646450
Recruitment Status : Unknown
Verified September 2015 by Betta Pharmaceuticals Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : July 20, 2012
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co., Ltd.

Tracking Information
First Submitted Date  ICMJE July 17, 2012
First Posted Date  ICMJE July 20, 2012
Last Update Posted Date September 9, 2015
Study Start Date  ICMJE July 2012
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2012)
Progression free survival [ Time Frame: 12 months ]
PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01646450 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2012)
  • Overall survival [ Time Frame: 24 months ]
    Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive.
  • Objective response rate [ Time Frame: 3-6 months ]
    Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.
  • Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 18 months ]
    Adverse events, Serious adverse events , incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients
Official Title  ICMJE An Open Lable, Single Arm, Phase IV Study of Icotinib as First-line Treatment in Elder NSCLC Patients With EGFR Mutation
Brief Summary A single arm, open label, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.
Detailed Description

A single arm, open label, prospective, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.

  • Primary endpoint to assess progression-free survival
  • Secondary endpoints to assess the overall survival, objective response rate, disease control rate and so on.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE Drug: Icotinib
Icotinib: 125mg, oral administration, three times per day.
Other Names:
  • BPI-2009
  • Commana
Study Arms  ICMJE Experimental: Icotinib
Icotinib: 125mg, oral administration, three times per day.
Intervention: Drug: Icotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 19, 2012)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2016
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
  • Positive EGFR Mutation.
  • No previous systemic anticancer therapy.
  • Male and female patients aged over 70 years.
  • Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
  • Provision of written informed consent.

Exclusion Criteria:

  • Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
  • Known severe hypersensitivity to icotinib or any of the excipients of this product.
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years to 80 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01646450
Other Study ID Numbers  ICMJE BD-IC-IV20
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Betta Pharmaceuticals Co., Ltd.
Study Sponsor  ICMJE Betta Pharmaceuticals Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Han Baohui, MD Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity
PRS Account Betta Pharmaceuticals Co., Ltd.
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP