A Phase 1 Study of LY2787106 in Cancer and Anemia
Condition: Anemia
MeSH terms: Anemia
Intervention: LY2787106; Iron Supplementation
Intervention description: Administered IV.; Administered orally.
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer Related Anemia

Summary:

      This study will evaluate the safety LY2787106 in participants with cancer and anemia. It will
      also evaluate when LY2787106 can improve anemia. This study has two parts: Part A is a dose
      escalation evaluation. Part B is an evaluation of LY2787106 at a defined dose given with and
      without iron supplementation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histological or cytological evidence of non-myeloid cancer (solid tumors,
             lymphomas or multiple myeloma) that is metastatic and/or incurable

          -  Have been treated with at least one systemic (oral, intravenous, or subcutaneous)
             anti-cancer therapy or regimen

          -  Have a hemoglobin of less than or equal to 11 grams/deciliter (g/dL)

          -  Have a hepcidin level of greater than or equal to 5 nanograms/milliliter (ng/mL)

          -  Have given written informed consent prior to any study-specific procedures

          -  Have adequate hematologic, hepatic, and renal organ function

          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or
             equal to 2

          -  Available for the duration of the study and willing to follow study procedures

          -  If male or female with reproductive potential: Must agree to use medically approved
             contraception during the trial and for 4 months following the last dose of study drug

          -  If female with child bearing potential: Have a negative serum pregnancy test

          -  Have an estimated life expectancy of greater than or equal to 12 weeks

        Exclusion Criteria:

          -  Have received treatment in the previous 21 days with, or have not recovered fully
             from, a drug that has not received regulatory approval for any indication

          -  Have received erythropoiesis-stimulating agents in the previous 21 days or red blood
             cell transfusions in the previous 14 days, or in the investigator's opinion, likely to
             need red blood cell transfusion more frequently than every 21 days

          -  Have received parenteral iron supplementation within the prior 14 days

          -  Have a documented history of pure red cell aplasia, thalassemia major or sickle cell
             disease

          -  Have a history of cirrhosis or major organ transplantation

          -  QTc greater than 470 millisecond (msec)

          -  Have evidence of clinically significant hemolysis or bleeding

          -  Have a clinically significant systemic infection within 14 days of enrollment

          -  Have a suspected or confirmed history of hemochromatosis.

          -  Have other serious preexisting medical conditions (left to the discretion of the
             investigator)

          -  Have symptomatic central nervous system malignancy or metastasis (screening not
             required)

          -  Have acute or chronic leukemia

          -  Are a female who is pregnant or lactating

          -  Have a history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
             (screening not required)

          -  Have received external beam radiotherapy to more than 25% of the bone marrow

          -  Have known clinically significant hypersensitivity to biologic agents

          -  Have received live vaccine(s) within 1 month of screening or with plans of doing that
             during the participation to the study

          -  Have a history of congestive heart failure with New York Heart Association (NYHA)
             Class greater than 2 (NYHA Class 1 and 2 are eligible), unstable angina or recent
             myocardial infarction (within 1 year prior to administration of study drug)