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NCT01598077 Clinical Trial

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

Esophageal Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01598077
Other study ID # CLJM716X2101
Secondary ID 2011-004865-33
Status Completed
Phase Phase 1
First received
Last updated
Start date July 2012
Est. completion date March 2014

Study information
Verified date April 2014
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• LJM716

Locations
Country Name City State
Canada Novartis Investigative Site Toronto Ontario
Korea, Republic of Novartis Investigative Site Seoul Korea
Spain Novartis Investigative Site Barcelona Catalunya
Taiwan Novartis Investigative Site Taipei
United States Massachusetts General Hospital SC-5 Boston Massachusetts
United States University of Chicago Medical Center University of Chicago (16) Chicago Illinois
United States University of Texas/MD Anderson Cancer Center UT MD Houston Texas
United States University of Utah / Huntsman Cancer Institute Huntsman Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Korea, Republic of,  Spain,  Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dose-limiting toxicities (DLTs) 4 weeks
Secondary Adverse events 4 months
Secondary Serious adverse events 4 months
Secondary Pharmacodynamic response to LJM716 in tumor tissue 3 months
Secondary Frequency of partial responses, complete responses and stable disease according to RECIST every 2 months
Secondary Serum concentration of antibodies to LJM716 18 months
Secondary Progression-free survival 18 months
Secondary Duration of response 18 months
Secondary Serum concentration of LJM716, 4 months
See also
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Recruiting NCT04644250 - Combination of Toripalimab and Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma Phase 2
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