A Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer



Status:Completed
Conditions:Breast Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:10/19/2013
Start Date:July 2012
End Date:June 2014
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

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A Phase I Study of LJM716 in Patients With Squamous Cell Carcinoma of Head and Neck, or HER2 Overexpressing Metastatic Breast Cancer or Gastric Cancer


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


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
We found this trial at
4
sites
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Salt Lake City, UT
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Boston, Massachusetts 02114
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Boston, MA
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Chicago, IL
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Houston, TX
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