Clinical trial NCT01598077: A Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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: 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
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-05-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Dose-limiting toxicities (DLTs)
timeFrame: 4 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 4 months
measure: Serious adverse events
timeFrame: 4 months
measure: Pharmacodynamic response to LJM716 in tumor tissue
timeFrame: 3 months
measure: Frequency of partial responses, complete responses and stable disease according to RECIST
timeFrame: every 2 months
measure: Serum concentration of antibodies to LJM716
timeFrame: 18 months
measure: Progression-free survival
timeFrame: 18 months
measure: Duration of response
timeFrame: 18 months
measure: Serum concentration of LJM716,
timeFrame: 4 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center University of Chicago (16)
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital SC-5
state: Massachusetts
city: Houston
country: United States
facility: University of Texas/MD Anderson Cancer Center UT MD
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah / Huntsman Cancer Institute Huntsman
state: Utah
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.