Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
The primary purpose of Parts A and B of this study is to determine a recommended dose level of prexasertib (an inhibitor of checkpoint kinase 1\[Chk-1\]) in combination with cisplatin and radiation therapy (Part A) or cetuximab and radiation therapy (Part B) in participants with locally advanced head and neck cancer.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Must be able to comply with the treatment plan and follow-up schedule
Must have diagnosis of head and neck squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls), hypopharynx, or larynx
Have adequate organ function
If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for six months following the last dose of study drug
If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 14 days of the first dose of study drug and must not be breast feeding
You may not be if
Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment
Must not have received any of the following prior therapies or treatments: systemic therapy for the study cancer, radiation therapy to the head and neck region, or curative-intent surgery in the head and neck region
Have evidence of a distant metastatic disease
Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C
Must not have a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months
Must not have a family history of long corrected QT interval (QTc) syndrome
Must not have known allergic reaction against any of the components of the study treatment
