A Randomized Phase II Study of GDC-0068, an Inhibitor to Akt, in Combination with Fluoropyrimidine Plus Oxaliplatin Chemotherapy (mFOLFOX6) in Patients with Locally Advanced or Metastatic Gastric or G...

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Reference: EUCTR2012-002080-10

A Randomized Phase II Study of GDC-0068, an Inhibitor to Akt, in Combination with Fluoropyrimidine Plus Oxaliplatin Chemotherapy (mFOLFOX6) in Patients with Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer. ESTUDIO ALEATORIZADO, EN FASE II, CON GDC 0068, UN INHIBIDOR DE AKT, EN COMBINACIÓN CON UNA FLUOROPIRIMIDINA MÁS QUIMIOTERAPIA DE OXALIPLATINO (mFOLFOX6) EN PACIENTES CON CANCER LOCALMENTE AVANZADO O GASTRICO METASTÁSICO DE LA UNIÓN GASTROESOFÁGICA

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Extract

To estimate the efficacy of GDC-0068 combined with mFOLFOX6 chemotherapy compared with placebo combined with mFOLFOX6 chemotherapy in patients with inoperable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, as measured by progression-free survival. Evaluar la eficacia de GDC 0068 combinado con quimioterapia mFOLFOX6 en comparación con placebo combinado con mFOLFOX6 en pacientes con adenocarcinoma gástrico o de la unión gastroesofágica localmente avanzado irresecable o metastásico, determinada mediante la supervivencia sin progresión.


Inclusion criteria

  • Inoperable locally advanced or metastatic or recurrent gastric or gastroesophageal adenocarcinoma,adenocarcinoma gastrico o gastroesofágico recurrente inoperable localmente avanzado o metastásico