drugset / Trial / NCT01461057
A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |