Dose Escalation Of Icotinib In Previously Treated Patients With Routine Dose

Betta Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Icotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01465243

BD-IC-IV01

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Icotinib

Experimental group

Description:

This is a single arm study.

Treatment:

Drug: Icotinib