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
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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

      Studienzentren finden

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden für Laien bearbeitet.

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden nicht geändert.

      Results Disclaimer

      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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