A Dose-Escalation Study in Participants With Advanced Cancer
Condition: Advanced Cancer
MeSH terms: Neoplasms
Intervention: LY2495655
Intervention description: administered intravenously
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastases; Neoplasm; Advanced Cancer; Metastatic Cancer

Summary:

      This study is a multicenter, open-label, dose-escalation phase 1 study of intravenous (IV)
      LY2495655 in participants with advanced cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 greater than 12 weeks

          -  Have a histological or cytological diagnosis of cancer (with the exception of breast
             or prostate cancer) that is advanced and/or metastatic, for which no proven effective
             therapy exists or the participant has declined anticancer therapy OR

          -  Have a histological or cytological diagnosis of metastatic breast or metastatic
             prostate cancer and receiving stable anti-hormone therapy for at least 2 months

          -  Have 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 therapies for cancer, including chemotherapy,
             radiotherapy, or any other investigational therapy, for at least 30 days (6 weeks for
             mitomycin-C or nitrosoureas) prior to study enrollment and have recovered from the
             acute effects of therapy. Participants receiving anti-hormone therapy as specified in
             criteria above are not excluded

        Exclusion Criteria:

          -  Have received treatment within 30 days of the initial dose of study drug with a drug
             that has not received regulatory approval for any indication

          -  Have serious preexisting medical conditions other than their cancer (at the discretion
             of the investigator)

          -  Have central nervous system malignancy or metastasis (screening not required)

          -  Have a history of severe chronic diseases that could interfere with either strength
             evaluation or body mass assessment during participation in this study including, but
             not limited to, ischemic disease (affecting the heart, brain, or extremities),
             uncontrolled hypertension, uncontrolled pain, severe chronic obstructive pulmonary
             disease, uncompensated heart failure (New York Heart Association Class III or IV),
             uncontrolled diabetes, or liver cirrhosis (Child-Pugh Class C)

          -  Have a history of inherited or acquired neuromuscular diseases including multiple
             sclerosis, muscular dystrophies, or myasthenia gravis

          -  Have active systemic inflammatory conditions including rheumatoid arthritis,
             dermatomyositis, severe arthrosis, or scleroderma

          -  Have unstable bone lesions, or any bone instability, fusion, arthroplasty, tendon
             repair, synovectomy, and so on, due to any of the before-mentioned conditions or due
             to accident that could interfere with completion of the physical tests in this
             protocol

          -  Have chronic glucocorticosteroid use greater than 10 mg of prednisone per day or
             equivalent

          -  Have known positive test results for hepatitis B surface antigen (HBSAg), or hepatitis
             C antibodies (HCAb). Screening is not required

          -  Have untreated hypothyroidism or hyperthyroidism

          -  Have history of seizures, convulsions (except previous febrile convulsions), or stroke

          -  Present with evidence of major depressive disorder, or history of obsessive compulsive
             disorder, significant psychiatric disease such as schizophrenia, bipolar disorder, or
             delirium

          -  Have depressive symptoms associated with their cancer that require treatment with any
             of the excluded drugs listed in protocol

          -  Have a previous history of discontinuation of a monoclonal antibody therapy due to
             allergy or severe infusion reaction

          -  Are scheduled to start or already receive any anti-cancer hormone treatments for
             breast or prostate cancer in the adjuvant or neoadjuvant setting