Phase 1 Study of TG01 and Erlotinib in Non-small Cell Lung Cancer (NCSLC) Patients

A Phase 1 Dose-Escalation Pharmacokinetic and Pharmacodynamic Study of TG01 Tablets in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients

This is a multicenter, open-label, phase 1, dose escalation study. The purpose is to determine the highest dose of TG01 that can be safely given to patients with Non-Small Cell Lung Cancer in combination with erlotinib.

Inclusion Criteria (include but are not limited to):

• Histogically or pathologically determined relapsed/recurrent Stage IIIb (plueral effusion) or IV NSCLC.
• Measurable or evaluable disease as defined by RECIST
• Must have failed at least one prior chemotherapy regimen or have refused chemotherapy.
• ECOG perfromance status of 0,1, or 2.

Exclusion Criteria (include but are not limited to):

• Radiation therapy (excluding CNS therapy) < 2 weeks, chemotherapy, non-cytotoxic investigational agents or high dose corticosteroids within 3 weeks of intitating therpy or patients who have not recovered from adverse effects due to agents administered more than 3 weeks earlier.
• Evidence of New York Heart Associatation Class III or greater cardiac disease.
• History of myocardial infarction, stroke, or cardiovascular intervention within the last 12 months.
• Patients on anti-platlet drugs or anticoagulants such as Placix and Coumadin.
• Systemic central nervous system metastases. The patient must be stable after radiotherapy for >/= to 2 weeks and off corticosteroids for >/= to 1 week.
• Pregnant or nursing women.
• Patients who are primarily refactory to erlotinib.