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Eine Studie zu Pertuzumab in Kombination mit Trastuzumab und Chemotherapie bei Teilnehmenden mit HER2-positivem metastasierendem Karzinom des ösophagogastralen Übergangs oder Magenkrebs (HER2: humaner epidermaler Wachstumsfaktor-Rezeptor-2)
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 (JACOB)
- Krebs
- Magenkrebs
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Abgeschlossen
Diese Studie läuft in
Städte
- Berlin
- Essen
- Esslingen am Neckar
- Hamburg
- Leipzig
- Ludwigsburg
- Mainz
- Mannheim
- Marburg
- Ulm
Studien-ID:
NCT01774786 2012-003554-83 BO25114
Studienzusammenfassung
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.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT01774786,BO25114,2012-003554-83
Studien-ID
5-Fluorouracil, Capecitabine, Cisplatin, Pertuzumab, Placebo, Trastuzumab
Treatments
Gastric Cancer
Condition
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
Einschlusskriterien
All
Gender
≥18 Years
Age
No
Healthy Volunteers
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
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