Study of Efficacy and Safety of LJM716 and Cetuximab in Head and Neck Squamous Cell Carcinoma Patients

April 19, 2016 updated by: Novartis Pharmaceuticals

A Phase Ib/II, Multicenter Study of LJM716 in Combination With Cetuximab in Patients With Platinum-pretreated Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

To establish whether LJM716 in combination with cetuximab is safe and has beneficial effects in patients with platinum-pretreated recurrent/metastatic head and neck squamous cell carcinoma.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Most recent regimen contains both platinum and cetuximab (Phase II, group B).
  • ECOG Performance Status (PS) ≤ 2.
  • Recovery from all AEs of previous anti-cancer therapies, to baseline or to CTCAE Grade ≤ 1, except for alopecia.
  • Measurable disease as determined by RECIST v1.1.

Exclusion Criteria:

  • Previous anti-HER3 antibody treatment.
  • Symptomatic brain metastasis.
  • Prior systemic anti-cancer treatment, within a period of time that is shorter than the cycle length used for that treatment prior to starting study treatment.
  • Prior anaphylactic or other severe infusion reaction to human immunoglobulin or antibody formulations.
  • Inadequate end organ function.
  • Ongoing diarrhea CTCAE Grade ≥ 2. Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LJM716+cetuximab
Biological: LJM716
antibody
Biological: cetuximab
antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase Ib: Target lesion change compared to baseline in patients, per RECIST 1.1
Time Frame: 6 months
Assessment of the preliminary anti-tumor activity of LJM716 in combination. Change in target lesion measurements, from baseline as per RECIST 1.1
6 months
Phase Ib: Number of Total Dose-limiting Toxicity (DLT) During Dose Escalation to Determine Maximum Tolerated Dose (MTD)
Time Frame: 35 days
The dose escalation part of the study will be guided by a well-established statistical method/model to estimate the maximum tolerated dose of LJM716 in combination with cetuximab
35 days
Phase II: Percentage of Patients with an Objective Overall Response (OOR) per RECIST 1.1
Time Frame: 6 months
Patients with an Objective Overall Response (OOR) were those whose best response to treatment was a complete response (CR) or a partial response (PR) assessed by imaging, as pr RECIST 1.1.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of the LJM716- cetuximab combination
Time Frame: 6 months
This will be assessed by looking at the number of Adverse Events (AEs), serious AEs (SAEs) changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions, reductions and dose intensity.
6 months
blood concentration versus time profiles blood PK parameters of LJM716 and cetuximab concentration
Time Frame: 6 months
blood concentration versus time profiles blood PK parameters will be used to characterize the PK profiles of LJM716 and cetuximab concentration when used in combination
6 months
Best overall response (BOR), per RECIST 1.1
Time Frame: 6 months
BOR will be used to further assess the anti-tumor activity of LJM716-cetuximab combination.
6 months
Duration of response (DOR) per RECIST 1.1
Time Frame: 6 months
Duration of response will be used to further assess the anti-tumor activity of LJM716-cetuximab combination
6 months
Overall survival (OS) per RECIST 1.1
Time Frame: 12 months
Overall survival will be used to further assess the anti-tumor activity of LJM716-cetuximab combination
12 months
Progression free survival (PFS) per RECIST 1.1
Time Frame: 6 months
Progression free survival will be used to further assess the anti-tumor activity of LJM716-cetuximab combination
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

May 19, 2014

First Submitted That Met QC Criteria

May 19, 2014

First Posted (Estimate)

May 21, 2014

Study Record Updates

Last Update Posted (Estimate)

April 21, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLJM716X2104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head and Neck Squamous Cell Carcinoma

Clinical Trials on LJM716

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe