Study of Efficacy and Safety of LJM716 and Cetuximab in Head and Neck Squamous Cell Carcinoma Patients
NCT ID: NCT02143622
Last Updated: 2016-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2015-03-31
2018-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LJM716+cetuximab
LJM716
antibody
cetuximab
antibody
Interventions
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LJM716
antibody
cetuximab
antibody
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Other Identifiers
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CLJM716X2104
Identifier Type: -
Identifier Source: org_study_id
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