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A Phase 1 Study of LY2874455 to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Patients With Advanced Cancer.

Phase 1
18 Years
Open (Enrolling)
Advanced Cancer

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Trial Information

A Phase 1 Study of LY2874455 to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Patients With Advanced Cancer.

Phase 1, first human dose study

Inclusion Criteria:

- Have histological or cytological evidence of a diagnosis of cancer (solid tumors,
lymphoma, or chronic lymphocytic leukemia) that is advanced and/or metastatic and for
which all standard therapies have failed

- Have the presence of measurable or nonmeasurable disease

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

- Have adequate organ function including:

- Hematologic: Absolute neutrophil count (ANC) equal to or greater than 1.5 x
10(9)/L platelets equal to or greater than 100 x 10(9)/L, and hemoglobin equal
to or greater than 8 g/dL. Patients may receive erythrocyte transfusions to
achieve this hemoglobin level at the discretion of the investigator. Initial
treatment must not begin until 14 days after the erythrocyte transfusion

- Hepatic: Bilirubin equal to or less than 1.5 times upper limits of normal (ULN),
alanine transaminase (ALT), and aspartate transaminase (AST) equal to or less
than 2.5 times ULN. If the liver has tumor involvement, AST and ALT equaling
equal to or less than 5 times ULN are acceptable

- Renal: Serum creatinine less than or equal to 1.2 times ULN or calculated
creatinine clearance greater than or equal to 60 milliliters per minute using
the Standard Cockcroft and Gault Creatinine Clearance Calculation

- Calcium and phosphate less than or equal to 1.1 times ULN

- Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group
(ECOG) scale

- Have discontinued chemotherapy and cancer-related hormonal therapy with commercially
available agents for at least 21 days (6 weeks for mitomycin-C or nitrosoureas) and
radiotherapy for at least 14 days prior to study enrollment and recovered from the
acute effects of therapy. Hormone refractory prostate cancer patients receiving
gonadotropin releasing hormone (GnRH) agonist therapy or breast cancer patients on
antiestrogen therapy (for example, an aromatase inhibitor) prior to entrance on the
study may have that treatment continued while they are enrolled in the study

- Females with childbearing potential must have had a negative serum pregnancy test
less than or equal to 7 days prior to the first dose of study drug. Males and females
with reproductive potential must agree to use 2 medically approved contraceptive
methods during the trial and for 3 months following the last dose of study drug.
Female patients must agree to use 2 medically acceptable methods of contraception, 1
being an oral contraceptive, dermal patch, or progestin (implantation or injection),
and the other being a medically acceptable barrier method Medically acceptable
barrier methods of contraception that may be used by the participant and/or his/her
partner include: abstinence; diaphragm with spermicide; intrauterine device (IUD);
condom together with foam, spermicide, or vaginal spermicidal suppository. Prohibited
methods include the rhythm method, withdrawal, condoms alone, or diaphragm alone

- Have an estimated life expectancy of greater than or equal to 12 weeks

Exclusion Criteria:

- Have received treatment with an investigational drug, which has not received
regulatory approval for any indication, within 28 days of study treatment with

- Currently taking agents to control serum phosphate or calcium levels. This includes
dietary restrictions

- Have medical conditions that, in the opinion of the investigator, would preclude
participation in this study

- Have symptomatic central nervous system (CNS) malignancy or metastasis. Patients with
treated CNS metastases are eligible provided their disease is radiographically
stable, asymptomatic, and they are not currently receiving corticosteroids and/or
anticonvulsants. Screening of asymptomatic patients without history of CNS metastases
is not required

- Have a history of major organ transplant (for example: heart, lungs, liver, and

- Have current acute leukemia

- Females who are pregnant or nursing

- An untreated or uncontrolled acute infection, including urinary tract infection,
within 7 days of study entry

- Have Bazett's corrected QT (QTcB) greater than 470 msec (female) or greater than 450
msec (male), history of unexplained recurrent syncope, history of congenital long QT
syndrome, family history of sudden death, or the presence in the screening
electrocardiogram (ECG) of a conduction abnormality that in the opinion of the
investigator would preclude safe participation in this study

- Have had an autologous or allogenic bone marrow transplant

- Previously treated with LY2874455

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended dose for Phase 2 studies

Outcome Time Frame:

Baseline to study completion

Safety Issue:


Principal Investigator

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

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


Australia: National Health and Medical Research Council

Study ID:




Start Date:

December 2010

Completion Date:

June 2014

Related Keywords:

  • Advanced Cancer
  • Advanced cancer
  • Metastatic cancer
  • Oncology
  • Neoplasms