Sanofi — Evoltra EMA EPAR variation assessment report (EMEA/H/C/000613, 2006)
Sanofi · 2006 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the assessment of a Phase 1/2 dose-escalation study (CLO21800205) of clofarabine combined with etoposide and cyclophosphamide in pediatric patients with refractory or relapsed acute leukemias. The study aimed to identify the maximum tolerated dose and recommended Phase 2 dose, and evaluate safety and efficacy. Although the regimen demonstrated some efficacy, particularly in facilitating transplant, it exhibited significant toxicity, including a high incidence of serious adverse events and deaths. This raised concerns regarding the overall benefit-risk profile at the recommended Phase 2 dose.
Key findings — cited to the page
| Patients with Grade 3 AE (Phase 2) | 4.0 % | CLO21800205 · p.7 |
| Patients with Grade 4 AE (Phase 1) | 44.0 % | CLO21800205 · p.7 |
| Patients with Grade 5 event (Phase 2) | 32.0 % | CLO21800205 · p.11 |
| Patients with Grade 5 AE (Phase 1) | 16.0 % | CLO21800205 · p.7 |
| Patients with Grade 5 AE (Phase 2) | 32.0 % | CLO21800205 · p.7 |
| Patients with Grade 4 AE (Phase 2) | 64.0 % | CLO21800205 · p.7 |
| Patients with Grade 3 event (Phase 2) | 4.0 % | CLO21800205 · p.11 |
| Patients with Grade 4 event (Phase 2) | 64.0 % | CLO21800205 · p.11 |
| Patients with Grade 3 AE (Phase 1) | 40.0 % | CLO21800205 · p.7 |
| Approval status of clofarabine (Evoltra) | approved under exceptional circumstances | Evoltra (clofarabine) · EU · p.2 |
| Data cut-off date | 11 May 2010 | CLO21800205 · p.3 |
| Overall response rate (Phase 1) | 64.0 % | CLO21800205 · p.10 |
Source: Sanofi ↗ · 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 →