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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01720901
First received: October 31, 2012
Last updated: June 26, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Icotinib
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Betta Pharmaceuticals Co.,Ltd.:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 4.5 months ] [ Designated as safety issue: No ]
    Progression-free survival is defined as a duration from the date that first dose is given to disease progression or death.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Overall survival is a duration from the date that first dose is given to the date of death.

  • Tumor response [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Adverse Events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Adverse events will be coded in term of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events.


Estimated Enrollment: 20
Study Start Date: February 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01720901     History of Changes
Other Study ID Numbers: BD-IC-IV41
Study First Received: October 31, 2012
Last Updated: June 26, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014