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

Amgen

Status and phase

Withdrawn

Phase 1

Conditions

Oncology

Non-Small Cell Lung Cancer

Treatments

Drug: AMG 954/Panitumumab

Study type

Interventional

Funder types

Industry

Identifiers

20040145

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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