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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00091806 |
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 | Intervention | Phase |
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Tumors Oncology Solid Tumors |
Drug: panitumumab (ABX-EGF) Drug: Panitumumab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label, Clinical Trial Evaluating the Safety and Pharmacokinetics of Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors |
Enrollment: | 86 |
Study Start Date: | August 2004 |
Study Completion Date: | October 2006 |
Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Cohort 1: Experimental
6mg/kg of panitumumab administered once every 2 weeks until subjects develop disease progression or are unable to tolerate the study drug
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Drug: panitumumab (ABX-EGF)
6 mg/kg once every 2 weeks
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Cohort 2: Experimental
Panitumumab 9 mg/kg administered once every 3 weeks until subjects develop disease progression or are unable to tolerate the study drug.
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Drug: Panitumumab
9 mg/kg once every 3 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
If history of other primary cancer, subject will be eligible only if she or he has:
Hematologic function, as follows:
Renal function, as follows:
o Creatinine < 2.0 mg/dL
Hepatic function, as follows:
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20030251 |
Study First Received: | September 17, 2004 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00091806 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; United States: Western Institutional Review Board |
Targeted Therapy Solid tumors ABX-EGF, panitumumab |
EGFr Immunex, Abgenix, Amgen Monoclonal Antibody |
Antibodies, Monoclonal Antibodies Immunoglobulins |