At a glance
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An Open-Label, Randomized, Multicenter Phase IIa Study Evaluating Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
In Brief
A Phase 2 clinical trial evaluating Capecitabine, Cisplatin, and 2 other interventions for Gastric Cancer. Completed, enrolled 30 participants across 24 sites in 8 countries.
Detailed Summary
This randomized, multicenter, open-label study will evaluate two different doses of pertuzumab in combination with Herceptin (trastuzumab) and chemotherapy in the first-line treatment of participants with metastatic HER2-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to two treatment arms. Participants in the Pertuzumab 840/420 mg Arm will receive a pertuzumab loading dose of 840 mg for Cycle 1 and a dose of 420 mg for Cycles 2-6, and participants in the Pertuzumab 840/840 mg Arm will receive pertuzumab 840 mg for all six cycles. Participants in both treatment arms will receive trastuzumab, cisplatin, and capecitabine.
Study Details
Timeline
Interventions
1000 mg/m2 twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle
80 mg/m2 on Day 1 of each cycle
loading dose of 840 mg, then 420 mg once every three weeks
840 mg once every three weeks
loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg for subsequent cycles