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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01720901
• Other study ID #: BD-IC-IV41
• Status: Suspended
• Phase: Phase 4
• First received: October 31, 2012
• Last updated: May 21, 2015
• Start date: February 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2015
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Xiangya Hospital, Central-South Univercity	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Progression-free survival is defined as a duration from the date that first dose is given to disease progression or death.	4.5 months	No
Secondary	Overall survival	Overall survival is a duration from the date that first dose is given to the date of death.	12 months	No
Secondary	Tumor response	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.	6 weeks	No
Secondary	Adverse Events	Adverse events will be coded in term of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events.	18 months	Yes