Amgen Inc. — Vectibix EMA EPAR variation assessment report (EMEA/H/C/000741, 2007)

Amgen Inc. · 2007 · EMA EPAR variation assessment report · company profile →

Report summary

This report summarizes the assessment of a pediatric study (Study 20050252) for panitumumab (Vectibix), conducted as a post-marketing commitment. The Phase 1, open-label, single-arm, dose-ranging study investigated safety, pharmacokinetics, and preliminary anti-tumor activity in children with solid tumors. Although no objective responses were achieved, some patients exhibited stable disease. The safety profile was consistent with that observed in adults. However, the study did not lead to a specific pediatric dose recommendation for panitumumab.

Key findings — cited to the page

Patients with treatment-related serious adverse events	4 patients	Study 20050252 · p.16
Percentage of patients with treatment-related serious adverse events	12.9 %	Study 20050252 · p.16
Patients with treatment-related serious adverse events in age 12 to <18 years group	1 patient	Study 20050252 · p.16
Patients with treatment-related serious adverse events in age 1 to <12 years group	3 patients	Study 20050252 · p.16
Fatal events	6 patients	Study 20050252 · p.17
Percentage of fatal events	19.4 %	Study 20050252 · p.17
Fatal events in age 12 to <18 years group	4 patients	Study 20050252 · p.17
Fatal events in age 1 to <12 years group	2 patients	Study 20050252 · p.17
First patient enrolled date	March 14, 2008	Study 20050252 · p.4
Patients with DLTs	5 patients	Study 20050252 · p.17
Percentage of patients with DLTs	22.7 %	Study 20050252 · p.17
Patients with dyspnea, hypoxia, vomiting (serious adverse events) in age 1 to <12 years group	2 patients	Study 20050252 · p.16

Source: Amgen Inc. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →