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| Sponsor: | Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00658658 |
Purpose
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 |
|---|---|---|
|
Solid Tumors |
Drug: Panitumumab Treatment |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Age and Dosing Cohort
Each Cohort will be stratified by age and dose; all cohorts will receive panitumumab as open-label treatment
|
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
|
Eligibility| Ages Eligible for Study: | 1 Year to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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, Oregon | |
| Research Site | Recruiting |
| Portland, Oregon, United States | |
| United States, Texas | |
| Research Site | Recruiting |
| Houston, Texas, United States | |
| Study Director: | MD | Amgen |
More Information
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00658658 History of Changes |
| Other Study ID Numbers: | 20050252 |
| Study First Received: | April 10, 2008 |
| Last Updated: | July 21, 2011 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
|
Epidermal Growth Factor Pediatric Solid Tumors Panitumumab Dose Limiting Toxicities |
Open-label Single Arm Phase 1 Interventional |
|
Neoplasms Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |