A Phase 1 Study in Participants With Advanced Cancer



Status:Completed
Conditions:Lung Cancer, Colorectal Cancer, Ovarian Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/11/2016
Start Date:February 2010
End Date:January 2016

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A Phase 1 Study of LY2606368 in Patients With Advanced Cancer

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).

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
We found this trial at
5
sites
Nashville, Tennessee 37203
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Oklahoma City, OK
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Sarasota, Florida 34232
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Sarasota, FL
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