An Open-Label Clinical Trial Evaluating the Safety and Pharmacodynamics of Sirolimus and Panitumumab in Subjects With Advanced Non-Small Cell Lung Cancer
Inclusion Criteria:
- Histologically- or cytologically-confirmed diagnosis of stage IIIB or IV Non-Small
Cell Lung Cancer
- Received only one prior treatment (not including radiation)
- Measurable disease per Response Evaluation Criteria in Solid Tumors Group (RECIST)
guidelines
- Life expectancy of ≥ 4 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematologic, renal and hepatic function
- Serum-fasting cholesterol ≤ 300 mg/dL Serum-fasting triglycerides ≤ 2.5 X ULN
Exclusion Criteria:
- Brain metastases requiring treatment
- History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial
pneumonitis or pulmonary fibrosis on baseline
- Systemic chemotherapy, radiotherapy, hormonal therapy or immunotherapy within 30 days
before enrollment
- Prior epidermal growth factor receptor targeting agents with the exception of the
small molecule EGFr tyrosine kinase inhibitors
- Prior anti-tumor therapies including prior experimental agents or approved anti-tumor
small molecules and biologics of short serum half-life (less than 1 week) within 30
days before enrollment, or prior experimental or approved proteins/antibodies with
longer serum half-life within 6 weeks before enrollment
- Prior therapy with sirolimus, sirolimus analogs
- Immunosuppressive agents within 28 days before enrollment