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

Phase 1

Completed

• Conditions: HER2 + Gastric Cancer; Esophageal Squamous Cell Carcinoma; HER2 + Breast Cancer; HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma; Squamous Cell Carcinoma of Head and Neck
• Interventions: Drug: LJM716

• Registration Number: NCT01598077
• Lead Sponsor: Novartis Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-04
• Study First Submitted QC: 2012-05-14
• Study First Posted: 2012-05-15
• Study Start: 2012-07
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-04
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose escalation and dose expansion	LJM716	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicities (DLTs)	4 weeks

Secondary Outcome Measures

Name	Time	Method
Serious adverse events	4 months
Serum concentration of antibodies to LJM716	18 months
Serum concentration of LJM716,	4 months
Frequency of partial responses, complete responses and stable disease according to RECIST	every 2 months
Adverse events	4 months
Pharmacodynamic response to LJM716 in tumor tissue	3 months
Progression-free survival	18 months
Duration of response	18 months

Trial Locations

Locations (5)

Novartis Investigative Site; 🇨🇳 Taipei, Taiwan

University of Chicago Medical Center University of Chicago (16); 🇺🇸 Chicago, Illinois, United States

Massachusetts General Hospital SC-5; 🇺🇸 Boston, Massachusetts, 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, United States