A Phase 1 Study of LY2874455 in Participants With Advanced Cancer
Condition: Advanced Cancer
MeSH terms: Neoplasms
Intervention: FGF Receptor; Phosphate Binders
Intervention description: LY2874455 administered orally.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced cancer; Metastatic cancer; Oncology

Summary:

      The study is to determine the recommended Phase 2 regimen of study drug that may be safely
      administered to participants with advanced and or metastatic cancer. The study consists of
      two parts: a dose escalation and a dose confirmation.
    

Eligibility criteria:

        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 non-measurable 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. Participants 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 participants receiving
             gonadotropin releasing hormone (GnRH) agonist therapy or breast cancer participants 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
             participants 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; alternatively, 2 medically
             acceptable barrier methods may be used. 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
             LY2874455

          -  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. Participants
             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 participants without history of CNS
             metastases is not required

          -  Have a history of major organ transplant (for example: heart, lungs, liver, and
             kidney)

          -  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