NCT01720901

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

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

• Status: Suspended
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-12-01
• Completion: 2016-12-01
• First posted: 2012-11-02
• Last updated: 2015-05-22

Locations

1 site across 1 country: China