NCT01465243

Dose Escalation Of Icotinib In Previously Treated Patients With Routine Dose

An Open , Single-Center, Single Arm Trial to Evaluate the Efficacy and Safety of Dose Escalation of Icotinib in Advanced NSCLC Patients After Routine Icotinib Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To determine whether dose escalation can provide a better survival to patients who failed with icotinib at routine dose.

Detailed description

Lung cancer is a major cause of morbidity and mortality, which is the rapidest increased type of cancer in China with over 5 times incidence rate increase during the past 30 years. Tyrosine kinase inhibitors (TKIs) of the epidermal growth factor receptor (EGFR) have been widely used for the treatment of patients with non-small cell lung cancer(NSCLC). Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. Icotinib appears to be non-inferior to Gefitinib in terms of efficacy, better in terms of safety, and larger of therapeutic window in phase I-III trials. In this study, an open , single-center, single arm phase IV trial was designed to evaluate the safety and efficacy of dose escalation of icotinib in the treatment of advanced NSCLC patients after failure with routine dose. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), TTP (time to progress), HRQOL and safety as the secondary end-point.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Icotinib	125 mg Tid (375 mg per day) 250 mg Tid (750 mg per day)

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-10-01
• Completion: 2014-02-01
• First posted: 2011-11-04
• Last updated: 2014-02-17

Locations

1 site across 1 country: China