From: Expanded Access Programme: looking for a common definition
Case model 1 Therapeutic area: Neoplasia | ||||
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Clinical study design | Target | Endpoints | Italian or international | Phase |
Multicentre, open-label, single-arm, expanded-access | Advanced stage carcinoma (inoperable or metastatic) | Primary: assess the safety and tolerability of long-term treatment | Italy and other European countries | Phase 3 |
Progressive disease after treatment with marketed drugs or intolerance | Secondary: assess progression-free and overall survival | |||
Patients not previously treated with the experimental drug (who has not participated in a clinical trial) |