A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) and Chemotherapy in Patients With HER2-Positive Metastatic Gastroesophageal Junction or Gastric Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overPharmaceutical / IndustryBO25114
NCT01774786

Trial Description

Summary

This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab), fluoropyrimidine and cisplatin as first-line treatment in patients with HER2-positive metastatic gastroesophageal junction or gastric cancer. Patients will be randomized to receive Perjeta 840 mg or placebo intravenously (iv) every 3 weeks in combination with Herceptin (initial dose of 8 mg/kg iv followed by 6 mg/kg iv every 3 weeks) and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Patients will continue to receive Perjeta or placebo and Herceptin until disease progression or unacceptable toxicity occurs.

Eligibility Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction
  • 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 >/= 3 months

Exclusion Criteria:

  • Previous cyctotoxic 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 peripheral bone metastases, if recovered from all toxicities)
  • History or evidence of brain metastases
  • Clinically significant active GI bleeding (Grade >/= 2 according to NIC-CTCAEv.4.03)
  • Other malignancy (in addition to 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 < 55%
  • Any significant uncontrolled intercurrent systemic illness
  • Positive for hepatitis B, hepatitis C or HIV infection

Trial Contact Information

Trial Lead Organizations/Sponsors

F. Hoffmann - La Roche, Limited

    Clinical Trials, Study Director
    Reference Study ID Number: BO25114 www.roche.com/about_roche/roche_worldwide.htm
    Ph: 888-662-6728 (U.S. Only)
    Email: global.rochegenentechtrials@roche.com

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01774786
    ClinicalTrials.gov processed this data on May 21, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.