A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer

• Status: Completed
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab, fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive metastatic gastroesophageal junction (GEJ) or gastric cancer (GC). Participants will be randomized to receive pertuzumab 840 milligrams (mg) or placebo intravenously every 3 weeks (q3w) in combination with trastuzumab (initial dose of 8 milligrams per kilogram [mg/kg] intravenously [IV] followed by 6 mg/kg IV q3w) and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Participants will continue to receive pertuzumab or placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Capecitabine; Cisplatin; Fluorouracil; Pertuzumab; Trastuzumab

Criteria

Inclusion Criteria:

• Histologically confirmed metastatic adenocarcinoma of the stomach or GEJ

• 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 greater than equal to (>/=) 3 months

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 bone metastases, if recovered from all toxicities)

• History or evidence of brain metastases

• Clinically significant active gastrointestinal (GI) bleeding (Grade >/=2 according to National Cancer Institute [NIC]-Common Terminology Criteria for Adverse Events Version 4.0 [CTCAEv.4.0])

• Residual toxicity resulting from previous therapy (for example, hematologic, cardiovascular, or neurologic toxicity that is Grade >/=2). Alopecia is permitted

• Other malignancy (in addition to gastric cancer [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 less than (<) 55 percent (%)

• Any significant uncontrolled intercurrent systemic illness

• Positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection