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Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy

Sponsor
Betta Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Suspended
CT.gov ID
NCT01720901
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
46
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the efficacy and safety of increased dose of icotinib in advanced NSCLC patients who progressed after gefitinib therapy.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

This single center, single arm open label study is designed to assess the safety and efficacy of using high dose of Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that progressed after routine gefitinib therapy by progression-free survival, as well as overall survival and disease control rate. The adverse events and adverse reaction are evaluated as well.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open, Single-Center,Single Arm Trial to Evaluate the Efficacy and Safety of Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy
Study Start Date :
Feb 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Icotinib

Icotinib will be administered 250 mg one time by month, 3 times per day.

Drug: Icotinib
Icotinib will be administered 250 mg one time by month, 3 times per day.
Other Names:
  • Conmana
  • BPI-2009

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival [4.5 months]

      Progression-free survival is defined as a duration from the date that first dose is given to disease progression or death.

    Secondary Outcome Measures

    1. Overall survival [12 months]

      Overall survival is a duration from the date that first dose is given to the date of death.

    2. Tumor response [6 weeks]

      Tumor response is designed by imaging according to Response Evaluation Criteria in Solid Tumors, including complete response, partial remission, stable disease as well as progressed disease.

    3. Adverse Events [18 months]

      Adverse events will be coded in term of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically or cytologically confirmed local advanced or metastatic stage IIIB/IV NSCLC.

    • Have been treated with gefitinib and achieved completed response, partial remission, or stable disease within 3 months after first dose of gefitinib.

    • At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors.

    • Signed and dated informed consent before the start of specific protocol procedures.

    Exclusion Criteria:

    • Allergic to icotinib.

    • Gefitinib excepted, experience of Anti-tumor Monoclonal Antibody or small molecular compounds therapy such as erlotinib or Cetuximab.

    • Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xiangya Hospital, Central-South Univercity Changsha Hunan China 410008

    Sponsors and Collaborators

    • Betta Pharmaceuticals Co., Ltd.

    Investigators

    • Principal Investigator: Hu Chengping, M.D., Xiangya Hospital, Central-South Univercity

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Betta Pharmaceuticals Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01720901
    Other Study ID Numbers:
    • BD-IC-IV41
    First Posted:
    Nov 2, 2012
    Last Update Posted:
    May 22, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Lung Neoplasms
    Small Cell Lung Carcinoma

    Study Results

    No Results Posted as of May 22, 2015