Clinical Trial Details

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Study ID CLJM716X2101
Novartis Pharmaceuticals,   Novartis Pharmaceuticals
Title A Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer
Conditions HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma
HER2 + Breast Cancer
HER2 + Gastric Cancer
Squamous Cell Carcinoma of Head and Neck
Esophageal Squamous Cell Carcinoma
Interventions Drug: LJM716
Phase Phase 1
Purpose This primary purpose of this study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) and preferred dosing schedule of LJM716 given by IV infusion in adult patients with squamous cell carcinoma of head and neck, or esophagus, or HER2 overexpressing metastatic breast cancer or gastric cancer
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Both
Accepts Healthy Volunteers:  No
Inclusion criteria:
  • Patients with HER2+ breast cancer, or HER2+ gastric cancer, or squamous cell carcinoma of head and neck, or esophageal squamous cell carcinoma
  • Site of disease that can be safely biopsied Exclusion criteria:
  • Patients received prior anti-HER3 antibody treatment
  • Patients with impaired cardiac function
  • Brain metastases that have not been adequately treated
  • Malignant disease other than that being treated in this study
  • Pregnant or nursing (lactating) women
  • Laboratory abnormalities as specified in the protocol Other protocol-defined inclusion/exclusion criteria may apply
  • Study Location N/A
    Contact N/A

    Information obtained from, on 8/3/2015. For additional information about this and other clinical trials, visit
    Please refer to this study by its identifier: NCT01598077

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