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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

NCT01598077 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2020-12-19

No results posted yet for this study

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

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

Interventions

DRUG

LJM716

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States
  • Canada
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01598077 on ClinicalTrials.gov