Head and Neck Neoplasms
Conditions
Keywords
cancer
Brief summary
The main purpose of this study is to investigate the safety of prexasertib in combination with other anti-cancer drugs (cisplatin or cetuximab) and radiation therapy in participants with locally advanced head and neck cancer. The study has two parts (A and B). Participants will only enroll in one part.
Detailed description
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.
Interventions
DRUGPrexasertib
Administered IV
DRUGCisplatin
Administered IV
DRUGCetuximab
Administered IV
RADIATIONIntensity Modulated Radiation Therapy
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Maximum Tolerated Dose of Prexasertib in Combination with Cisplatin and Radiation Therapy | First Dose through Last Dose (Estimated up to 7 Weeks) |
| Part B: Maximum Tolerated Dose of Prexasertib in Combination with Cetuximab and Radiation Therapy | First Dose through Last Dose (Estimated up to 8 Weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum Concentration of Prexasertib, Cisplatin and Cetuximab | First Dose through Last Dose (Estimated up to 8 Weeks) |
| PK: Area Under the Concentration Curve (AUC) of Prexasertib | First Dose through Last Dose (Estimated up to 8 Weeks) |
| Locoregional Control Rate | Baseline through One Year (Estimated as up to 52 Weeks) or Death from Any Cause |
Countries
France, United States
Outcome results
None listed