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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00658658 |
This is an open-label, multi-center, single arm, dose-ranging, phase 1, clinical study. Panitumumab will be administered by IV infusion to 4-6 subjects 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 subjects. Upon demonstration of sufficient safety additional cohorts will open; a 2.5 mg/kg once weekly administration to the 1 to < 12 year old subjects and a 6.0 mg/kg once every two weeks to the 12 to < 18 year old subjects. The decision to advance to the next cohort will be based on observance of </= 33% subject 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 subjects and 9.0 mg/kg once every three weeks to both age groups will open once sufficient safety in each cohort is determined. Subjects may stay on study treatment until disease progression.
Condition | Intervention | Phase |
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Solid Tumors |
Drug: Panitumumab Treatment |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Panitumumab in Children With Solid Tumors |
Estimated Enrollment: | 36 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Age and Dosing Cohort: Experimental
Each Cohort will be stratified by age and dose; all cohorts will receive panitumumab as open-label treatment
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Drug: Panitumumab Treatment
Panitumumab will be given to all cohorts according to dose and age. Enrollment for subsequent cohorts will be determined according to a safety assessment by a Data Review Team made up of investigators and key members of the Amgen study team
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Ages Eligible for Study: | 1 Year to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Amgen Call Center | 866-572-6436 |
United States, California | |
Research Site | Recruiting |
San Francisco, California, United States | |
United States, District of Columbia | |
Research Site | Recruiting |
Washington, District of Columbia, United States | |
United States, Minnesota | |
Research Site | Recruiting |
Minneapolis, Minnesota, United States | |
United States, New York | |
Research Site | Recruiting |
New York, New York, United States | |
United States, Texas | |
Research Site | Recruiting |
Houston, Texas, United States |
Study Director: | MD | Amgen |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20050252 |
Study First Received: | April 10, 2008 |
Last Updated: | February 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00658658 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Pediatric Solid Tumors Panitumumab Dose Limiting Toxicities Open-label |
Single Arm Phase 1 Interventional Epidermal Growth Factor |
Mitogens |