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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01598077
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : April 23, 2014
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
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
Study Start Date : July 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: Dose escalation and dose expansion Drug: LJM716

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01598077

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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
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01598077     History of Changes
Other Study ID Numbers: CLJM716X2101
2011-004865-33 ( EudraCT Number )
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: April 23, 2014
Last Verified: April 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:
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Breast Neoplasms
Carcinoma, Squamous Cell
Stomach Neoplasms
Esophageal Squamous Cell Carcinoma
Squamous Cell Carcinoma of Head and Neck
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 Neoplasms
Head and Neck Neoplasms
Esophageal Diseases