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

Launched by TRAGARA PHARMACEUTICALS, INC. · Dec 5, 2007

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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.