drugset / Trial / NCT01461057

A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer

NCT01461057 ↗

Phase 2 Completed 30 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2011-12-06
Primary completion
2015-03-01
Completion
2017-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pertuzumab Monoclonal antibody 420 mg Intravenous
Subject Pertuzumab Monoclonal antibody 840 mg Intravenous
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Cisplatin Other / unclassified 80 mg/m2 Intravenous
Background Trastuzumab Monoclonal antibody 6 mg/kg Intravenous

Indications