Bayer Aktiengesellschaft — Stivarga EMA EPAR variation assessment report (EMEA/H/C/002573, 2013)
Bayer Aktiengesellschaft · 2013 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the EMA's assessment of Stivarga (regorafenib) for pediatric use, focusing on a Phase I dose-escalation study (Study 15906) in children with recurrent or refractory solid tumors. The study evaluated regorafenib as monotherapy and in combination with vincristine and irinotecan to determine its safety, pharmacokinetic profile, maximum tolerated dose (MTD), and recommended Phase II dose (RP2D). The report details safety and efficacy outcomes, including adverse event rates, overall response rate, and survival data from both escalation and expansion phases. It comprehensively outlines treatment-emergent adverse events (TEAEs), serious adverse events (TESAEs), and dose-limiting toxicities (DLTs), highlighting common and severe toxicities, and drug-related TEAEs across different dose levels and treatment regimens.
Key findings — cited to the page
| Grade 5 drug-related TEAEs | 0 | · p.30 |
| participants with drug-related TEAE of worst Grade 3 or Grade 4 | 15 | · p.30 |
| participants with worst grade TEAEs (Grade 3 or higher) (expansion phase) | 20 | · p.31 |
| Grade 5 events (expansion phase) | 2 | · p.31 |
| participants with TEAE of worst Grade 3 or higher | 34 | · p.30 |
| Grade 3 ALT increased (drug-related TEAEs) (Expansion; SAF) | 23.8 % | · p.42 |
| percentage of participants with worsening by 4 grades for White blood cell count decreased in expansion phase | 4.8 % | · p.54 |
| Grade 3 AST increased (drug-related TEAEs) (Expansion; SAF) | 19 % | · p.42 |
| highest incidence of severe (Grade >=3) drug-related TEAEs | 90.5 % | · p.43 |
| Neutropenia Grade 3 or 4 (drug-related TEAEs) (Expansion; SAF) | 47.6 % | · p.42 |
| Anaemia Grade 3 or 4 (drug-related TEAEs) (Expansion; SAF) | 38.1 % | · p.42 |
| TEAEs Grade ≥3 (Expansion; SAF) | 20 participants | · p.32 |
Source: Bayer Aktiengesellschaft ↗ · 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 →