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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
Cliniques Universitaires St-Luc
Brussels, Belgium
UZ Leuven Gasthuisberg
Leuven, Belgium
Masaryk Memorial Cancer Institute; Oncological Clinic
Brno, Czechia
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
Hradec Králové, Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, Czechia
Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni
Prague, Czechia
University Hospital Na Bulovce; Institut of Radiation Oncology
Prague, Czechia
Hopital Morvan
Brest, France
CRLCC Val dAurelle Paul Lam
Montpellier, France
Hopital Robert Debre; DERMATOLOGIE
Reims, France
...and 14 more locations
Percentage of Participants With Day 43 Serum Pertuzumab Trough Concentrations (Cmin) Greater Than or Equal to (>=) 20 Microgram Per Milliliter (mcg/mL)
Time frame: Day 43
Number of Participants With Adverse Events (AEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.
Time frame: From randomization of first participant to end of study (approximately 6 years)
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