Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT02350712
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed recurrent disease or metastatic SCCHN originating from the oral cavity, oropharynx, hypopharynx, and larynx
* Has documented disease recurrence following prior treatment
* Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Has adequate hematological function, per protocol
* Has adequate renal function, per protocol
* Has adequate hepatic function, per protocol
* Has prothrombin time (PT) or partial thromboplastin time (PTT) within 1.5 x upper limit of normal (ULN)
* Has a negative serum pregnancy test performed within 14 days prior to enrollment (where required by local regulations, test may be required within 72 hours prior to enrollment), if a woman of child-bearing potential
* Agrees to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last study dose received, if of child-bearing potential
* Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Exclusion Criteria:
* Has left ventricular ejection fraction (LVEF) \< 50%
* Has received prior epidermal growth factor receptor (EGFR) targeted regimen
* Has received prior anti-HER2, anti-HER3, or anti-HER4 therapy
* Has received prior treatment for recurrent/metastatic disease
* Has history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
* Has known history of and active brain metastases
* Has uncontrolled hypertension (systolic \> 160 mm Hg or diastolic \> 100 mm Hg)
* Has clinically significant electrocardiogram (ECG) changes
* Has had myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure (New York Heart Association \>Class II), unstable angina, or unstable cardiac arrhythmia requiring medication
* Had platinum-containing drug therapy/chemotherapy with radiotherapy \< 6 months before study drug treatment
* Had therapeutic or palliative radiation therapy or major surgery within 4 weeks before study drug treatment.
* Participated in clinical drug trials within 4 weeks before study drug treatment or is currently participating in other investigational procedures
* Has uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, active hepatitis B or C infection, or is undergoing medical treatment for infection
* Has uncontrolled type 1 or 2 diabetes mellitus
* Has known hypersensitivity or allergic reaction against any of the components of the trial treatment
* Is pregnant, breastfeeding, or unwilling/unable to use acceptable contraception
* Has psychological, social, familial, or geographical factors that would interfere with study participation or follow up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02350712
Study Brief:
Protocol Section:
NCT02350712