A randomized, multicenter, open-label study evaluating two different doses of pertuzumab in patients with HER2-positive advanced gastric cancer

Update Il y a 4 ans
Reference: EUCTR2011-002331-25

Woman and Man

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Extract

• To estimate the minimum (trough) pertuzumab concentration (Cmin) at Day 43 for two dose levels of pertuzumab in order to identify a dose that produces a steady-state Cmin of ≥ 20 μg/mL in 90% of patients receiving pertuzumab and trastuzumab plus chemotherapy as first-line treatment for HER2-positive inoperable locally advanced or recurrent and/or metastatic adenocarcinoma of the stomach or gastroesophageal junction • To evaluate the safety and tolerability of two dose levels of pertuzumab in combination with trastuzumab and chemotherapy administered every 3 weeks to patients with HER2-positive inoperable locally advanced or recurrent and/or metastatic adenocarcinoma of the stomach or gastroesophageal junction


Inclusion criteria

  • HER2-positive adenocarcinoma of the stomach or gastroesophageal junction