Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02143622
Recruitment Status : Withdrawn
First Posted : May 21, 2014
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Biological: LJM716 Biological: cetuximab Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: LJM716+cetuximab Biological: LJM716
antibody

Biological: cetuximab
antibody




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143622


Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02143622    
Other Study ID Numbers: CLJM716X2104
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Head and neck cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Carcinoma
Carcinoma, Squamous Cell
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents