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A Blinded, Randomized, Phase 1/2 Study of Brivanib Alaninate vs. Placebo in Combination with Erbitux and Irinotecan in K-Ras wild type Subjects with Metastatic Colorectal Cancer. Revised Protocol 0...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-005097-31

A Blinded, Randomized, Phase 1/2 Study of Brivanib Alaninate vs. Placebo in Combination with Erbitux and Irinotecan in K-Ras wild type Subjects with Metastatic Colorectal Cancer. Revised Protocol 03 (v5.0, dated 2 July 2008) incorporating Protocol Amendment 04 (v1.0, dated 2 July 2008). And Pharmacogenetics Blood Sample Amendment 01. Estudio fase 1/2, enmascarado y aleatorizado de brivanib alaninato frente a placebo en combinación con Erbitux e Irinotecán en sujetos con cáncer colorrectal metastásico con K-Ras de tipo natural. Protocolo revisado 03 (v5.0, 02-Julio-08) incorporando la enmienda al protocolo 04(v1.0, 2 -Julio- 2008) y enmienda 01 de muestra de sangre para farmacogénética

Femme et Homme

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Extrait

Part 1: To define the recommended dose of brivanib that can be safely administered in combination with Erbitux and irinotecan to K-Ras wild type subjects with advanced metastatic colorectal cancer (MCRC). Part 2: To compare median duration of progression free survival (PFS) in the 2 treatment arms Part 2: To compare median duration of progression free survival (PFS) in the 2 treatment arms

Critère d'inclusion

  • Patients with advanced metastatic colorectal cancer (MCRC),Pacientes con cáncer colorrectal metastásico avanzado

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