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

NCT01461057

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Gastric Cancer

Interventions: Capecitabine, Cisplatin, Pertuzumab, Pertuzumab, Trastuzumab

Countries: Belgium, Czechia, France, Germany, Italy, Netherlands, South Korea, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Adult participants, greater than or equal to (\>=) 18 of age
* Adenocarcinoma of the stomach or gastroesophageal junction with inoperable locally advanced or metastatic disease, not amenable to curative therapy
* Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST), v1.1
* HER2-positive tumor
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy of at least 3 months

Exclusion Criteria:

* Previous chemotherapy for advanced or metastatic disease (except (prior adjuvant or neoadjuvant therapy at least 6 months before enrollment in the study)
* Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
* Active (significant or uncontrolled) gastrointestinal bleeding
* Abnormal laboratory values

Locations (24)

Brussels, Belgium
Leuven, Belgium
Brno, Czechia
Hradec Králové, Czechia
Olomouc, Czechia
Prague, Czechia
Prague, Czechia
Brest, France
Montpellier, France
Reims, France
Berlin, Germany
Braunschweig, Germany
Frankfurt, Germany
Mannheim, Germany
Catanzaro, Calabria, Italy
Milan, Lombardy, Italy
Pisa, Tuscany, Italy
Maastricht, Netherlands
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Barcelona, Spain
Madrid, Spain
Valencia, Spain