A Phase 1 Study in Participants With Advanced Cancer

Lilly

Status and phase

Completed

Phase 1

Conditions

Advanced Cancer

Squamous Cell Carcinoma

Lung Squamous Cell Carcinoma Stage IV

Anal Squamous Cell Carcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell of Head and Neck

Treatments

Drug: Prexasertib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01115790

13129

I4D-MC-JTJA (Other Identifier)

Details and patient eligibility

About

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.

Full description

Part C added per protocol amendment (February, 2013).

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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