The purpose of this study is to evaluate the safety and pharmacokinetics of two dose schedules of panitumumab in subjects with advanced solid tumors.

Condition	Treatment or Intervention	Phase
Tumor	Drug: panitumumab (ABX-EGF)	Phase I

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Pathologic diagnosis of advanced solid tumors that are refractory to standard treatment or for which no standard therapy is available. Tumor must be evaluated by standard criteria for the specific tumor type.
• Eastern Cooperative Oncology Group of 0, 1 or 2
• Measurable disease or evaluate (non-measurable) disease per RECIST guidelines
• Life expectancy of > 3 months
• Adequate hematologic, renal and hepatic function

Exclusion Criteria:

• Symptomatic brain metastases requiring treatment
• Patient with a history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis
• Use of systemic chemotherapy or radiotherapy within 30 days before enrollment
• Prior epidermal growth factor receptor targeting agents with the exception of the small molecule EFGr tyrosine kinase inhibitors
• Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than 1 week) serum half-life within 30 days before enrollment, or prior experimental or approved proteins within 3 months before enrollment

Amgen Call Center      866-572-6436 

Colorado
      Research Site, Denver,  Colorado,  United States; Recruiting
Minnesota
      Research Site, Robbinsdale,  Minnesota,  United States; Recruiting
North Carolina
      Research Site, Charlotte,  North Carolina,  United States; Recruiting
Texas
      Research Site, Dallas,  Texas,  United States; Recruiting

Study ID Numbers:  20030251
Record last reviewed:  October 2004
Record first received:  September 17, 2004
ClinicalTrials.gov Identifier:  NCT00091806
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10