Cheplapharm — Xeloda EMA EPAR variation assessment report (EMEA/H/C/000316, 2001)
Cheplapharm · 2001 · EMA EPAR variation assessment report
Report summary
This report assesses a Type II variation for Xeloda (capecitabine) by Roche Registration Ltd, focusing on the final report of paediatric phase II study NO21125. This study investigated capecitabine with radiation therapy in children with newly diagnosed brainstem gliomas. The study failed to meet its primary endpoint, showing no improvement in 1-year progression-free or overall survival compared to historical data. The observed safety profile was primarily attributed to radiation therapy, not capecitabine.
Key findings — cited to the page
| Procedure Number | EMEA/H/C/000316/II/0058 | Xeloda · p.1 |
| Variation Type | C.I.13 | Xeloda · p.2 |
| Study Type | single arm, multicentre, open label trial | NO21125 · p.3 |
| Age range of patients | ≥3 and <18 years of age | NO21125 · p.3 |
| Capecitabine starting dose (RT phase) | 1300 mg/m2 daily | NO21125 · p.3 |
| Capecitabine starting dose (post-RT phase) | 2500 mg/m2 daily | NO21125 · p.3 |
| Patients enrolled | 35 | NO21125 · p.4 |
| ITT population | 34 | NO21125 · p.4 |
| 1-year PFS (ITT population) | 8 % | NO21125 · p.5 |
| 1-year PFS (historical control group) | 15 % | NO21125 · p.5 |
| 1-year OS (ITT population) | 42 % | NO21125 · p.5 |
| CNS necrosis (SAE) | 7 % | NO21125 · p.5 |
Source: Cheplapharm ↗ · 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 →