a phase 1 study in participants with advanced cancer

Conditions: Advanced Cancer; Squamous Cell Carcinoma; Carcinoma, Squamous Cell of Head and Neck; Lung Squamous Cell Carcinoma Stage IV; Anal Squamous Cell Carcinoma; Carcinoma, Non-Small-Cell Lung

Summary: 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).

Eligibility criteria:
inclusion criteria: * must be appropriate candidate for experimental therapy, as determined by investigator, after available standard therapies have failed * have adequate organ function * prior therapies: systemic treatments: must have discontinued previous systemic treatments for cancer and recovered from the acute effects of therapy. participants must have discontinued mitomycin-c or nitrosourea therapy at least 42 days and have discontinued any cytotoxic therapies at least 28 days prior to study enrollment. radiation therapy and surgery: must be completed at least 4 weeks before study enrollment * part a: must have diagnosis of cancer that is advanced or metastatic * part b: must have histologically confirmed squamous cell cancer of the head and neck or must have squamous cell cancer of any tumor type * part c: must have histological diagnosis of squamous cell cancer of the head and neck, histological or cytological diagnosis of squamous non-small-cell lung cancer, or histological diagnosis of stage iiib (n2 or n3) or stage iv squamous cell cancer of the anus that is not curable by local therapy * must be available during the duration of the study and willing to follow the study procedures * if participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three 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 7 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 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 systolic blood pressure \<90 millimeters of mercury (mmhg) or recurrent symptomatic orthostatic hypotension * must not have a family history of long qtc syndrome or be taking drugs known to cause qtc prolongation or torsades de pointes * must not have a serotonin-secreting carcinoid tumor or a prior history of drug-induced serotonin syndrome * must not have acute leukemia