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

  • Cancer
  • Gastric Cancer
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Countries
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Croatia
  • El Salvador
  • Finland
  • Germany
  • Guatemala
  • Hungary
  • Italy
  • Japan
  • Kazakhstan
  • Malaysia
  • Mexico
  • Netherlands
  • North Macedonia
  • Peru
  • Poland
  • Romania
  • Russia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey
  • United States
Trial Identifier:

NCT01774786 2012-003554-83 BO25114

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT01774786,BO25114,2012-003554-83 Trial Identifier
      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

      Eligibility Criteria

      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

      For the latest version of this information please go to www.forpatients.roche.com

       

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