This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: May 4, 2012
Last updated: April 21, 2014
Last verified: April 2014
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

Condition Intervention Phase
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 Drug: LJM716 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Dose-limiting toxicities (DLTs) [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 4 months ]
  • Serious adverse events [ Time Frame: 4 months ]
  • Pharmacodynamic response to LJM716 in tumor tissue [ Time Frame: 3 months ]
  • Frequency of partial responses, complete responses and stable disease according to RECIST [ Time Frame: every 2 months ]
  • Serum concentration of antibodies to LJM716 [ Time Frame: 18 months ]
  • Progression-free survival [ Time Frame: 18 months ]
  • Duration of response [ Time Frame: 18 months ]
  • Serum concentration of LJM716, [ Time Frame: 4 months ]

Enrollment: 54
Study Start Date: July 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose escalation and dose expansion Drug: LJM716


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01598077

United States, Illinois
University of Chicago Medical Center University of Chicago (16)
Chicago, Illinois, United States, 60546
United States, Massachusetts
Massachusetts General Hospital SC-5
Boston, Massachusetts, United States, 02114
United States, Texas
University of Texas/MD Anderson Cancer Center UT MD
Houston, Texas, United States, 77030-4009
United States, Utah
University of Utah / Huntsman Cancer Institute Huntsman
Salt Lake City, Utah, United States, 84103
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 110 744
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site
Taipei, Taiwan, 10002
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01598077     History of Changes
Other Study ID Numbers: CLJM716X2101
2011-004865-33 ( EudraCT Number )
Study First Received: May 4, 2012
Last Updated: April 21, 2014

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Squamous Cell
Stomach Neoplasms
Esophageal Neoplasms
Head and Neck Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Esophageal Diseases processed this record on September 21, 2017