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Disposition of [14C]LY2603618 Following Intravenous Administration in Patients With Advanced and/or Metastatic Solid Tumors

Phase 1
18 Years
Not Enrolling
Advanced Cancer

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Trial Information

Disposition of [14C]LY2603618 Following Intravenous Administration in Patients With Advanced and/or Metastatic Solid Tumors

Inclusion Criteria:

- Have a histological or cytological diagnosis of cancer (solid tumor), with clinical
or radiologic evidence of locally advanced and/or metastatic disease, for which no
life-prolonging therapy exists (that is, refractory to standard therapy and/or
therapies known to provide clinical benefit, or for which no standard therapy exists)
Note: Patients who have had progressive disease after receiving pemetrexed for
metastatic disease are excluded from receiving the combination with pemetrexed during
the safety extension study. Patients who have had progressive disease after receiving
gemcitabine for metastatic disease are excluded from receiving the combination with
gemcitabine during the safety extension study.

- Have a body surface area greater than or equal to 1.37 m^2

- Have given written informed consent prior to any study-specific procedures

- Adequate hematologic, hepatic and renal function

- Have a performance status of less than or equal to 2 on the Eastern Cooperative
Oncology Group (ECOG) scale

- Have discontinued all previous treatments for cancer, including chemotherapy,
radiotherapy, anticancer hormone therapy, or other investigational therapy for at
least 30 days prior to study entry and recovered from the acute effects of therapy
(at least 42 days for mitomycin-C or nitrosoureas, or 60 days for monoclonal

- Are reliable and willing to make themselves available for the duration of the study
and are willing to follow study procedure

- Males and females with reproductive potential: Must agree to use medically approved
contraceptive precautions during the study and following the last dose of study drug
until, in the judgment of the investigator, it is safe for the patient to become
pregnant or father a child

- Females with childbearing potential: Have had a negative serum pregnancy test less
than or equal to 7 days before the first dose of study drug and must also not be

- Have an estimated life expectancy that, in the judgment of the investigator, will
permit the patient to complete 1 full cycle of treatment (beyond the initial
[14C]LY2603618 dose)

- Prior radiation therapy for treatment of cancer other than pancreatic is allowed to
<25% of the bone marrow and patients must have recovered from the acute toxic effects
of their treatment prior to study enrollment. Prior radiation to the whole pelvis is
not allowed. Prior radiotherapy must be completed at least 4 weeks before study

Exclusion Criteria:

- Have received treatment within 28 days of the initial dose of study drug with an
experimental agent for noncancer indications that has not received regulatory
approval for any indication

- Have previously completed or withdrawn from this study or any other study
investigating LY2603618 or any other checkpoint kinase one (Chk1) inhibitor

- Have a known allergy to gemcitabine, pemetrexed, LY2603618, or any ingredient of
gemcitabine, pemetrexed, or LY2603618 (like Captisol)

- Have serious preexisting medical conditions (left to the discretion of the
investigator) other than advanced cancer

- Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not
required). Patients with treated CNS metastases are eligible for this study if they
are not currently receiving corticosteroids and/or anticonvulsants, and their disease
is asymptomatic and radiographically stable for at least 90 days

- Have current hematologic malignancies or either acute or chronic leukemia

- Have an active fungal, bacterial, and/or known viral infection including HIV or viral
(A, B, or C) hepatitis (screening is not required)

- Have a QTc interval of >500 msec on the screening electrocardiogram (ECG)

- Have electrocardiogram (ECG) abnormalities on the screening ECG such as significant
conduction abnormalities, ischemic changes (such as prior Q-wave myocardial
infarction and/or marked ischemic ST- and T-wave), arrhythmias (such as persistent or
paroxysmal ventricular or supraventricular arrhythmias, including atrial
fibrillation), or other ECG abnormalities that would put the patient at unnecessary
risk in the opinion of the investigator

- Have participated in a 14C study within the last 6 months prior to screening for this
study. The total exposure from this study and the previous study must be less than 5

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Urinary and fecal excretion of LY2603618 radioactivity over time expressed as a percentage of the total radioactive dose administered

Outcome Time Frame:

7 days

Safety Issue:


Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT- 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


United States: Food and Drug Administration

Study ID:




Start Date:

February 2011

Completion Date:

February 2012

Related Keywords:

  • Advanced Cancer
  • metastatic solid tumors
  • Malignant/M-Neoplasm
  • Pancreas NOS
  • Absorption
  • Distribution
  • Metabolism
  • Excretion
  • Mass balance
  • Metabolic profile
  • Radiolabeled study
  • Neoplasms