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

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
LJM716
cetuximab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma focused on measuring Head and neck cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    LJM716+cetuximab

    Arm Description

    Outcomes

    Primary Outcome Measures

    Phase Ib: Target lesion change compared to baseline in patients, per RECIST 1.1
    Assessment of the preliminary anti-tumor activity of LJM716 in combination. Change in target lesion measurements, from baseline as per RECIST 1.1
    Phase Ib: Number of Total Dose-limiting Toxicity (DLT) During Dose Escalation to Determine Maximum Tolerated Dose (MTD)
    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
    Phase II: Percentage of Patients with an Objective Overall Response (OOR) per RECIST 1.1
    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

    Safety and tolerability of the LJM716- cetuximab combination
    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.
    blood concentration versus time profiles blood PK parameters of LJM716 and cetuximab concentration
    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
    Best overall response (BOR), per RECIST 1.1
    BOR will be used to further assess the anti-tumor activity of LJM716-cetuximab combination.
    Duration of response (DOR) per RECIST 1.1
    Duration of response will be used to further assess the anti-tumor activity of LJM716-cetuximab combination
    Overall survival (OS) per RECIST 1.1
    Overall survival will be used to further assess the anti-tumor activity of LJM716-cetuximab combination
    Progression free survival (PFS) per RECIST 1.1
    Progression free survival will be used to further assess the anti-tumor activity of LJM716-cetuximab combination

    Full Information

    First Posted
    May 19, 2014
    Last Updated
    April 19, 2016
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02143622
    Brief Title
    Study of Efficacy and Safety of LJM716 and Cetuximab in Head and Neck Squamous Cell Carcinoma Patients
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    August 2018 (Anticipated)
    Study Completion Date
    August 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Squamous Cell Carcinoma
    Keywords
    Head and neck cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LJM716+cetuximab
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    LJM716
    Intervention Description
    antibody
    Intervention Type
    Biological
    Intervention Name(s)
    cetuximab
    Intervention Description
    antibody
    Primary Outcome Measure Information:
    Title
    Phase Ib: Target lesion change compared to baseline in patients, per RECIST 1.1
    Description
    Assessment of the preliminary anti-tumor activity of LJM716 in combination. Change in target lesion measurements, from baseline as per RECIST 1.1
    Time Frame
    6 months
    Title
    Phase Ib: Number of Total Dose-limiting Toxicity (DLT) During Dose Escalation to Determine Maximum Tolerated Dose (MTD)
    Description
    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
    Time Frame
    35 days
    Title
    Phase II: Percentage of Patients with an Objective Overall Response (OOR) per RECIST 1.1
    Description
    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.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Safety and tolerability of the LJM716- cetuximab combination
    Description
    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.
    Time Frame
    6 months
    Title
    blood concentration versus time profiles blood PK parameters of LJM716 and cetuximab concentration
    Description
    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
    Time Frame
    6 months
    Title
    Best overall response (BOR), per RECIST 1.1
    Description
    BOR will be used to further assess the anti-tumor activity of LJM716-cetuximab combination.
    Time Frame
    6 months
    Title
    Duration of response (DOR) per RECIST 1.1
    Description
    Duration of response will be used to further assess the anti-tumor activity of LJM716-cetuximab combination
    Time Frame
    6 months
    Title
    Overall survival (OS) per RECIST 1.1
    Description
    Overall survival will be used to further assess the anti-tumor activity of LJM716-cetuximab combination
    Time Frame
    12 months
    Title
    Progression free survival (PFS) per RECIST 1.1
    Description
    Progression free survival will be used to further assess the anti-tumor activity of LJM716-cetuximab combination
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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