Safety Evaluation of Panitumumab and Sirolimus in Advanced Non-Small Cell Lung Cancer

• Status: Withdrawn
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the dose and schedule of sirolimus when given in combination with panitumumab in adult subjects with Stage IIIB/IV NSCLC

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Everolimus; Panitumumab; Sirolimus

Criteria

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