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

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ClinicalTrials.gov Identifier: NCT01720901
Recruitment Status : Suspended (Accrual limitations)
First Posted : November 2, 2012
Last Update Posted : May 22, 2015
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co.,Ltd.

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
Non-small Cell Lung Cancer Drug: Icotinib 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : February 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 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 [ Time Frame: 12 months ]
    Overall survival is a duration from the date that first dose is given to the date of death.

  2. Tumor response [ Time Frame: 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 [ Time Frame: 18 months ]
    Adverse events will be coded in term of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT01720901


Locations
China, Hunan
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

Responsible Party: Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01720901     History of Changes
Other Study ID Numbers: BD-IC-IV41
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action