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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
University of Alabama at Birmingham Medical Center
Birmingham, Alabama, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Centre Leon Berard
Lyon, France
Gustave Roussy
Villejuif, France
Part A: Maximum Tolerated Dose of Prexasertib in Combination with Cisplatin and Radiation Therapy
Time frame: First Dose through Last Dose (Estimated up to 7 Weeks)
Part B: Maximum Tolerated Dose of Prexasertib in Combination with Cetuximab and Radiation Therapy
Time frame: First Dose through Last Dose (Estimated up to 8 Weeks)
Pharmacokinetics (PK): Maximum Concentration of Prexasertib, Cisplatin and Cetuximab
Time frame: First Dose through Last Dose (Estimated up to 8 Weeks)
PK: Area Under the Concentration Curve (AUC) of Prexasertib
Time frame: First Dose through Last Dose (Estimated up to 8 Weeks)
Locoregional Control Rate
Time frame: Baseline through One Year (Estimated as up to 52 Weeks) or Death from Any Cause
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.