A Study of LY2228820 in Participants With Advanced Cancer
Condition: Advanced Cancer
MeSH terms: Neoplasms
Intervention: LY2228820; Midazolam; Tamoxifen
Intervention description: Administered orally
Intervention MeSH terms: Tamoxifen; Midazolam
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to determine a safe dose of LY2228820 that may be given to
      participants with advanced cancer. Part A of this study will consist of dose escalation, and
      Part B will consist of dose confirmation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histological or cytological evidence of a diagnosis of cancer (including
             lymphoma) that is advanced or metastatic disease for which no therapy of higher
             priority (approved therapies or therapies with published substantial evidence of
             effectiveness) is available, or for whom no standard therapy exists

          -  Have the presence of measurable or nonmeasurable disease as defined by Modified
             Response Evaluation Criteria in Solid Tumors (mRECIST)

          -  Have adequate hematologic, renal, and hepatic organ function

          -  Have a performance status of less than or equal to 2 on the Eastern Cooperative
             Oncology Group (ECOG) scale

          -  Have discontinued all previous therapies for cancer, including chemotherapy,
             radiotherapy, or other investigational therapy for at least 14 days (42 days for
             mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute
             effects of therapy

          -  Males and females with reproductive potential must agree to use medically approved
             contraceptive precautions during the trial and for 3 months following the last dose of
             study drug

          -  Females with child bearing potential must have had a negative serum pregnancy test
             less than or equal to 7 days prior to the first dose of study drug

          -  Have an estimated life expectancy of ≥ 12 weeks

          -  Are able to swallow capsules and/or tablets

        Exclusion Criteria:

          -  Have received treatment within 14 days of the initial dose of study drug with a drug
             that has not received regulatory approval for any indication

          -  Have a history of major surgical resection involving the stomach or small bowel, or
             have serious preexisting medical conditions (based on judgment of the investigator)

          -  Have symptomatic central nervous system malignancy or metastasis (screening is not
             required)

          -  Have a diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis)

          -  Have an active hematologic malignancy other than lymphoma

          -  Have known positive test results in human immunodeficiency virus (HIV), hepatitis B
             surface antigen (HBSAg), or hepatitis C antibodies (HCAb). Screening at baseline will
             not be required for enrollment

          -  Concurrent administration of any immunosuppressive therapy

          -  Females who are pregnant or lactating

          -  Have received, within 7 days of the initial dose of study drug, either grapefruit
             juice or treatment with a drug that is a known inhibitor or inducer of Cytochrome P450
             Enzyme 3A4 (CYP3A4). In addition, participants should not receive grapefruit juice or
             treatment with a CYP3A4 inhibitor or inducer during the study