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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01598077
First received: May 4, 2012
Last updated: April 21, 2014
Last verified: April 2014
  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


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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

Primary Outcome Measures:
  • Dose-limiting toxicities (DLTs) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Serious adverse events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Pharmacodynamic response to LJM716 in tumor tissue [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Frequency of partial responses, complete responses and stable disease according to RECIST [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
  • Serum concentration of antibodies to LJM716 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Serum concentration of LJM716, [ Time Frame: 4 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01598077

Locations
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
Spain
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Taiwan
Novartis Investigative Site
Taipei, Taiwan, 10002
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01598077     History of Changes
Other Study ID Numbers: CLJM716X2101, 2011-004865-33
Study First Received: May 4, 2012
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Spain: Ministry of Health
Korea: Food and Drug Administration
Taiwan : Food and Drug Administration

Keywords provided by Novartis:
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
Carcinoma, Squamous Cell
Esophageal Neoplasms
Head and Neck Neoplasms
Neoplasms, Squamous Cell
Stomach Neoplasms
Breast Diseases
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Skin Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on November 19, 2014