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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
Not Recruiting
Trial ID: NCT01774786
Purpose
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.
Official Title
A Double-Blind, Placebo-Controlled, Randomized, Multicenter Phase III Study Evaluating the Efficacy and Safety of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Metastatic Gastroesophageal Junction and Gastric Cancer
Eligibility
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
Intervention(s):
drug: 5-fluorouracil
drug: capecitabine
drug: cisplatin
drug: placebo
drug: Pertuzumab
drug: Trastuzumab
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061