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Phase II, Multicenter, Open-label, Single Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified b...

Update Il y a 4 ans
Reference: EUCTR2007-005933-12

Phase II, Multicenter, Open-label, Single Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology

Woman and Man

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Extract

In patients with medullary thyroid cancer [MTC] or radioiodine (131I) refractory/resistant differentiated thyroid cancer[DTC]: Determine the effect of E7080 on the objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) by independent imaging review (IIR) Determine the pharmacokinetic (PK) profile and the pharmacokinetic/pharmacodynamic (PK/PD) relationships of E7080

Inclusion criteria

  • Medullary thyroid cancer [MTC] or radioiodine(131I) refractory/resistant differentiated thyroid cancer[DTC]

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