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
Completed · Phase 3 · Has a placebo group
Conditions studied: Gastric Cancer
In brief
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.
Key facts
- Study ID
- NCT01774786
- Run by
- Hoffmann-La Roche
- People needed
- 780
- Starts
- 2013-06-10
- Expected to finish
- 2019-12-31
- Last updated by the study team
- 2020-12-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University Of Chicago Medical Center; Section Of Hematology/Oncology — Chicago, Illinois, United States
- Indiana University Health; Goshen Center for Cancer Care — Goshen, Indiana, United States
- Comprehensive Cancer Centers of Nevada - Eastern Avenue — Las Vegas, Nevada, United States
- New York Oncology Hematology, P.C. — Albany, New York, United States
- Queens Medical Associates — Fresh Meadows, New York, United States
- Weill Medical College of Cornell University; Division of Hematology & Medical Oncology — New York, New York, United States
- Oncology Hematology Care — Cincinnati, Ohio, United States
- Medical University of South Carolina; Hollings Cancer Center — Charleston, South Carolina, United States
- Tennessee Oncology PLLC - Nashville (20th Ave) — Nashville, Tennessee, United States
- Royal Brisbane Womens Hosp; Division of Oncology — Herston, Queensland, Australia
- Monash Medical Centre; Oncology — Clayton, Victoria, Australia
- Austin Health; Cancer Clinical Trial Centre — Heidelberg, Victoria, Australia
- Sir Charles Gairdner Hospital; Medical Oncology — Perth, Western Australia, Australia
- Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt. — Salzburg, Austria
- Krankenhaus St. Vinzenz Der Barmherzigen Schwestern Zams; Abt. Für Innere Medizin — Zams, Austria
- Cliniques Universitaires St-Luc — Brussels, Belgium
- Clinicas Oncologicas Integradas - COI — Rio de Janeiro, Rio de Janeiro, Brazil
- Hospital Nossa Senhora da Conceicao — Porto Alegre, Rio Grande do Sul, Brazil
- Hospital das Clinicas - UFRGS — Porto Alegre, Rio Grande do Sul, Brazil
- Centro de Pesquisas Oncologicas - CEPON — Florianópolis, Santa Catarina, Brazil
- Hospital Sirio Libanes; Centro de Oncologia — São Paulo, São Paulo, Brazil
- Clinica de Oncologia Medica — São Paulo, São Paulo, Brazil
- Hospital A. C. Camargo; Oncologia — São Paulo, São Paulo, Brazil
- Universidade Federal de Sao Paulo - UNIFESP*X — São Paulo, São Paulo, Brazil
- Florida Cancer Specialists - SCRI; Pharmacy — Fort Myers, Florida, United States
Full record on ClinicalTrials.gov
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