Eisai Co., Ltd. — Halaven EMA EPAR variation assessment report (EMEA/H/C/002084, 2011)
Eisai Co., Ltd. · 2011 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the assessment of a pediatric study (E7389-G000-213) for Halaven (eribulin) combined with irinotecan in refractory/recurrent solid tumors. The study, encompassing Phase 1 dose determination and Phase 2 efficacy evaluation, was prematurely terminated due to low efficacy. Only three partial responses were observed across all histology cohorts. Importantly, no new safety concerns emerged from the combination therapy despite the limited efficacy.
Key findings — cited to the page
| subjects with treatment-related Grade 3 or higher TEAEs (Phase 2) | 24 subjects | Study E7389-G000-213 · p.10 |
| subjects with Grade 3 or higher TEAEs (Phase 1) | 12 subjects | Study E7389-G000-213 · p.10 |
| subjects with Grade 3 or higher TEAEs of special interest (Phase 1) | 13 subjects | Study E7389-G000-213 · p.11 |
| subjects with Grade 3 or higher TEAEs of special interest (Phase 2) | 21 subjects | Study E7389-G000-213 · p.11 |
| study type | Phase 1/2 open-label, single-arm, multicentre study | Study E7389-G000-213 · p.4 |
| eribulin dose (Phase 1) | 1.4 mg/m2 | Study E7389-G000-213 · p.5 |
| subjects with at least 1 TEAE (Phase 1) | 13 subjects | Study E7389-G000-213 · p.10 |
| irinotecan dose (Schedule B, Phase 1) | 100 mg/m2 | Study E7389-G000-213 · p.6 |
| subjects with at least 1 SAE (Phase 1) | 5 subjects | Study E7389-G000-213 · p.10 |
| irinotecan dose (Schedule B, Phase 1) | 125 mg/m2 | Study E7389-G000-213 · p.6 |
| enrolment (Phase 1) | 13 subjects | Study E7389-G000-213 · p.6 |
| irinotecan dose (Schedule A, Phase 1) | 40 mg/m2 | Study E7389-G000-213 · p.6 |
Source: Eisai Co., Ltd. ↗ · 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 →