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

NCT ID: NCT01720901

Last Updated: 2015-05-22

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2016-12-31

Brief Summary

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

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Icotinib

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

Group Type: EXPERIMENTAL

Icotinib

Intervention Type: DRUG

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

Interventions

Icotinib

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

Intervention Type: DRUG

Other Intervention Names

Conmana; BPI-2009

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Betta Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hu Chengping, M.D.

Role: PRINCIPAL_INVESTIGATOR

Xiangya Hospital, Central-South Univercity

Locations

Xiangya Hospital, Central-South Univercity

Changsha, Hunan, China

Countries

China

Other Identifiers

BD-IC-IV41

Identifier Type: -

Identifier Source: org_study_id