The primary purpose of Parts A and B of this study is to evaluate the safety and toxicity of prexasertib (an inhibitor of checkpoint kinase 1\[chk 1\]) in participants with advanced or metastatic cancer (Part A), or squamous cell cancer of the head and neck or squamous cell cancer of any tumor type (Part B). Part C of the study will evaluate prexasertib in three different groups of participants; those with squamous cell cancer of the head and neck that has recurred or spread to other parts of the body, those with squamous non-small cell lung cancer that has recurred or spread, and those with squamous cell cancer of the anus that is not curable by existing therapy.
Part C added per protocol amendment (February, 2013).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Prexasertib IV on day 1 of a 14 day cycle. The expected duration is 3 cycles (2 weeks each for a total of 6 weeks). Participants receiving clinical benefit may remain on study until disease progression, unacceptable toxicity or other criteria for discontinuation are met.
Florida Cancer Specialists
Sarasota, Florida, United States
Peggy and Charles Stephenson Oklahoma Cancer Center
Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Determination of a Recommended Phase 2 Dosing Regimen: Maximum Tolerated Dose (Parts A and B)
Time frame: Time of first dose until last dose (estimated as up to 156 weeks)
Determination of Clinically Significant Safety Effects (Parts A and B)
Time frame: Time of first dose until last dose (estimated as up to 156 weeks)
Percentage of Participants With a Complete or Partial Response (Overall Response Rate) (Part C)
Time frame: Baseline until disease progression or death from any cause (estimated as up to 24 weeks)
Percentage of Participants with Complete Response, Partial Response, or Stable Disease (Disease Control Rate) (Parts A, B, and C)
Time frame: Baseline until disease progression or death from any cause (estimated as up to 24 weeks)
Progression Free Survival (Parts B and C)
Time frame: Baseline to measured progressive disease (estimated up to 24 weeks)
Duration of Response (Parts B and C)
Time frame: First observation of complete response (CR), partial response (PR), or stable disease (SD) to first observation of progressive disease or death (estimated up to 24 weeks)
Preliminary Pharmacokinetics of Prexasertib (Cmax) (Parts A, B, and C)
Time frame: During Cycles 1 and 2
Preliminary Pharmacokinetics of Prexasertib (AUC) (Parts A, B, and C)
Time frame: During Cycles 1 and 2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.