Pfizer Inc. — Sutent EMA EPAR variation assessment report (EMEA/H/C/000687, 2006)
Pfizer Inc. · 2006 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes a Phase I/II clinical trial (Study A6181196) evaluating sunitinib in six pediatric and young adult patients with advanced, unresectable gastrointestinal stromal tumor (GIST). The study assessed pharmacokinetic profiles, safety, and preliminary anti-tumor efficacy. While no objective responses were observed, 50% of patients achieved stable disease, with a median progression-free survival of 5.8 months. Safety analysis revealed 83.3% of patients experienced Grade 3 or 4 adverse events, but no Grade 5 events or deaths occurred. Overall, the safety profile was consistent with that seen in adults, though the small sample size limits definitive conclusions.
Key findings — cited to the page
| patients with Grade 2 decrease in neutrophils (absolute) | 4 | Study A6181196 · p.16 |
| overall incidence of TEAEs of any grade | 100 % | Study A6181196 · p.15 |
| patients with Grade 2 decrease in WBC | 6 | Study A6181196 · p.16 |
| patients with Grade 1 hemoglobin increased | 1 | Study A6181196 · p.16 |
| patients with Grade 1 decrease in platelets | 3 | Study A6181196 · p.16 |
| patients with Grade 3 or 4 AEs | 5 | Study A6181196 · p.14 |
| patients with Grade 1 anaemia | 2 | Study A6181196 · p.16 |
| patients with Grade 3 anaemia | 1 | Study A6181196 · p.16 |
| patients with Grade 3 AE | 3 | Study A6181196 · p.15 |
| patients with Grade 4 AE | 2 | Study A6181196 · p.15 |
| patients with Grade 3 platelets decreased | 1 | Study A6181196 · p.16 |
| patients with Grade 5 TEAEs | 0 | Study A6181196 · p.15 |
Source: Pfizer 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 →