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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
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

Thank you

Trial Information

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

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicities (DLTs)

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLJM716X2101

NCT ID:

NCT01598077

Start Date:

July 2012

Completion Date:

June 2014

Related Keywords:

  • 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
  • Breast cancer, gastric cancer, squamous cell carcinoma of head and neck, esophageal squamous cell carcinoma
  • Breast cancer
  • Gastric cancer
  • Squamous cell carcinoma of head and neck
  • Esophageal squamous cell carcinoma
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Stomach Neoplasms
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

Name

Location
University of Utah / Huntsman Cancer Institute Huntsman Salt Lake City, Utah  84103
University of Chicago Medical Center University of Chicago (16) Chicago, Illinois  60546
Massachusetts General Hospital SC-5 Boston, Massachusetts  02114
MD Anderson Cancer Center/University of Texas UT MD Houston, Texas  77030-4009