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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

NCT ID: NCT01598077

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-03-31

Brief Summary

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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

Detailed Description

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Conditions

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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

Keywords

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose escalation and dose expansion

Group Type EXPERIMENTAL

LJM716

Intervention Type DRUG

Interventions

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LJM716

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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University of Chicago Medical Center University of Chicago (16)

Chicago, Illinois, United States

Site Status

Massachusetts General Hospital SC-5

Boston, Massachusetts, United States

Site Status

University of Texas/MD Anderson Cancer Center UT MD

Houston, Texas, United States

Site Status

University of Utah / Huntsman Cancer Institute Huntsman

Salt Lake City, Utah, United States

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Taipei, , Taiwan

Site Status

Countries

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United States Canada South Korea Spain Taiwan

References

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Reynolds KL, Bedard PL, Lee SH, Lin CC, Tabernero J, Alsina M, Cohen E, Baselga J, Blumenschein G Jr, Graham DM, Garrido-Laguna I, Juric D, Sharma S, Salgia R, Seroutou A, Tian X, Fernandez R, Morozov A, Sheng Q, Ramkumar T, Zubel A, Bang YJ. A phase I open-label dose-escalation study of the anti-HER3 monoclonal antibody LJM716 in patients with advanced squamous cell carcinoma of the esophagus or head and neck and HER2-overexpressing breast or gastric cancer. BMC Cancer. 2017 Sep 12;17(1):646. doi: 10.1186/s12885-017-3641-6.

Reference Type DERIVED
PMID: 28899363 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=13604

Results for CLJM716X2101 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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2011-004865-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLJM716X2101

Identifier Type: -

Identifier Source: org_study_id