HER2-positive metastatic gastroesophageal junction or gastric cancer
Conditions
Interventions
investigational material(s)
Generic name etc : pertuzumab
INN of investigational material : pertuzumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigatio
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction - Measurable or evaluable non-measurable disease as assessed by the investigator according to RECIST v1.1 criteria - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Life expectancy >/= 3 months
Exclusion criteria
Exclusion criteria: - Previous cytotoxic chemotherapy for advanced (metastatic) disease - Evidence of disease progression documented within 6 months after completion of prior neoadjuvant or adjuvant cytotoxic chemotherapy, or both, or radiotherapy for GEJ adenocarcinoma - Previous treatment with any HER2-directed therapy, at any time, for any duration - Previous exposure to any investigational treatment within 30 days before the first dose of study treatment - Radiotherapy within 30 days before the first dose of study treatment (within 2 weeks if given as palliation to peripheral bone metastases, if recovered from all toxicities) - History or evidence of brain metastases - Clinically significant active GI bleeding (Grade >/= 2 according to NCI-CTCAEv.4.03) - Other malignancy (in addition to GC) within 5 years before enrollment, except for carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin that has been previously treated with curative intent - Inadequate hematologic, renal or liver function - Pregnant or lactating women - History of congestive heart failure of any New York Heart Association (NYHA) criteria - Angina pectoris requiring treatment - Myocardial infarction within the past 6 months before the first dose of study drug - Clinically significant valvular heart disease or uncontrollable high-risk cardiac arrhythmia - History or evidence of poorly controlled hypertension - Baseline left ventricular ejection fraction (LVEF) value < 55% - Any significant uncontrolled intercurrent systemic illness - Positive for hepatitis B, hepatitis C or HIV infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Overall survival Time from randomization to death of any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics other Progression-free survival: Time from randomization to first occurrence of disease progression, as determined by the investigator according to RECIST v1.1 criteria, or death of any cause Overall objective response (partial response + complete response) : Response occurring on two consecutive occasions >/= 4 weeks apart, as determined by the investigator according to RECIST v1.1 criteria Duration of objective response: Time from occurrence of objective response to progressive disease, as determined by investigator according to RECIST v1.1 criteria, or death of any cause Clinical benefit rate: Best response of complete response or partial response or stable disease for 6 weeks or longer, as determined by the investigator according to RECIST v1.1 criteria Safety: Incidence of adverse events and left ventricular systolic dysfunction (symptomatic or asymptomatic) | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Outcome results
None listed