Clinical trial NCT01465243: Dose Escalation Of Icotinib In Previously Treated Patients With Routine Dose
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-small Cell Lung Cancer
Keywords: Efficacy
Safety
EGFR-TKI
phase IV
NSCLC
Dose escalation
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-11-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Confirmed NSCLC with Histology or cytology; advanced （IIIb/IV).
2. Must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior chemotherapy must be completed at least 4 weeks before study enrollment.
3. Measurable, evaluable disease outside of a radiation port.

Exclusion Criteria:

1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
2. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.

Primary outcomes:
measure: Progression-free Survival
timeFrame: 6-12 months
Secondary outcomes:
measure: Overall survival
timeFrame: 6 months -1 year
measure: Objective response rate
timeFrame: 3-6 months
measure: Time to progression
timeFrame: 3-6 months
measure: Health-Related Quality of Life (HR QOL)
timeFrame: 1 year
measure: Number of Participants with adverse events and serious adverse events (SAEs)
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: 307 Hospital of People's Liberation Army（PLA）
state: Beijing
Study officials:
affiliation: 307 Hospital of People's Liberation Army（PLA）
name: Li Xi qing, M.D.
role: PRINCIPAL_INVESTIGATOR
References: