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A Phase 1b/2 trial studying how well lenvatinib works in treating children and adolescents with different types of cancer that are not responding to treatment or have reappeared following an initial r...

Mise à jour : Il y a 4 ans
Référence : EUCTR2013-005534-38

A Phase 1b/2 trial studying how well lenvatinib works in treating children and adolescents with different types of cancer that are not responding to treatment or have reappeared following an initial recovery

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Extrait

Cohort 1 (Single-Agent Dose-Finding)  Identify the recommended dose (RD) of lenvatinib as a single agent in children and adolescents with relapsed or refractory solid malignant tumors Cohort 2 (Single-Agent Expansion)  Evaluate the activity of lenvatinib in 2 separate malignancy groups: o Cohort 2A: 131I- refractory differentiated thyroid cancer: by objective response rate (ORR) o Cohort 2B: Relapsed or refractory osteosarcoma: by progression-free survival at 4 months (PFS)-4 Cohort 3 (Combination Dose-Finding and Expansion)  Cohort 3A (Combination Dose-Finding) To identify the RD of lenvatinib in combination with ifosfamide and etoposide in osteosarcoma subjects  Cohort 3B (Combination Expansion) o Evaluate the activity of lenvatinib in combination with ifosfamide and etoposide in osteosarcoma subjects by PFS-4

Critère d'inclusion

  • Refractory or relapsed solid malignancies

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