Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT 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.
Study:
NCT00658658
Study Brief:
Protocol Section:
NCT00658658