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Brief Title: Panitumumab in Children With Solid Tumors
Official Title: A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Panitumumab in Children With Solid Tumors
Study ID: NCT00658658
Brief Summary: The primary objective of this study was to evaluate the safety and pharmacokinetics of up to 3 different dose schedules of panitumumab in pediatric patients with solid tumors.
Detailed Description: This is an open-label, multi-center, single arm, dose-ranging, clinical study. Panitumumab will be administered by intravenous infusion to 4-6 patients per cohort. Three planned cohorts, stratified by age, will be studied at 100% of the recommended panitumumab dose for each treatment schedule as defined in adults. Enrollment will start with a 2.5 mg/kg once weekly administration to the 12 to \< 18 year old patients. Upon demonstration of sufficient safety additional cohorts will open; a 2.5 mg/kg once weekly administration to the 1 to \< 12 year old patients and a 6.0 mg/kg once every two weeks to the 12 to \< 18 year old patients. The decision to advance to the next cohort will be based on observance of ≤ 33% incidence of a dose limiting toxicity during the evaluation period. Subsequent cohorts of 6.0 mg/kg once every two weeks to the 1 to \< 12 year old patients and 9.0 mg/kg once every three weeks to both age groups will open once sufficient safety in each cohort is determined. Participants may stay on study treatment until disease progression.
Minimum Age: 1 Year
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Research Site, Los Angeles, California, United States
Research Site, San Francisco, California, United States
Research Site, Washington, District of Columbia, United States
Research Site, Chicago, Illinois, United States
Research Site, Minneapolis, Minnesota, United States
Research Site, Kansas City, Missouri, United States
Research Site, New York, New York, United States
Research Site, Cleveland, Ohio, United States
Research Site, Portland, Oregon, United States
Research Site, Nashville, Tennessee, United States
Research Site, Houston, Texas, United States
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR