A Study of LY2835219 in Japanese Participants With Advanced Cancer
Condition: Neoplasm Metastasis; Lymphoma
MeSH terms: Neoplasm Metastasis
Intervention: LY2835219
Intervention description: Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate safety and side effects of LY2835219 in
      Japanese participants with advanced cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histological or cytological evidence of a diagnosis of cancer (either a solid
             tumor or a lymphoma) that is advanced and/or metastatic

          -  Must be, in the judgment of the investigator, an appropriate candidate for the
             experimental therapy after available standard therapies have failed to provide
             clinical benefit for their disease

          -  Have the presence of measurable or non-measurable disease as defined by the Response
             Evaluation Criteria in Solid Tumors Guideline Version 1.1, or the Revised Response
             Criteria for Malignant Lymphoma Guideline

          -  Have adequate organ function

          -  Have discontinued all previous therapies for cancer, including chemotherapy,
             radiotherapy, immunotherapy, and investigational therapy, for at least 21 days before
             the first dose of study drug and recovered from the acute effects of any such therapy

          -  Males must agree to use medically approved barrier contraceptive precautions during
             the study and for 3 months following the last dose of study drug

          -  Females with child bearing potential: must agree to use medically approved
             contraceptive precautions during the study and for 3 months following the last dose of
             study drug, must have had a negative serum or urine pregnancy test ≤7 days before the
             first dose of study drug.

          -  A breastfeeding woman must not be breastfeeding. If a female who stops breastfeeding
             enters the study, the female must stop breastfeeding from the day of the first study
             drug administration until at least 3 months after the last administration

          -  Have an estimated life expectancy of ≥12 weeks

          -  Are able to swallow capsules

        Exclusion Criteria:

          -  Have received treatment within 21 days of the initial dose of study drug with an
             experimental agent for noncancer indications that has not received regulatory approval
             for any indication

          -  Have a medical history of any of the following conditions: presyncope or syncope of
             either unexplained or cardiovascular etiology, ventricular arrhythmia (e.g.,
             ventricular tachycardia and ventricular fibrillation) or sudden cardiac arrest

          -  Have a baseline with any of the following findings on screening electrocardiogram
             (ECG): ventricular tachycardia, ventricular fibrillation, abnormal QTc using Bazett's
             formula (QTcB) (defined as ≥470 milliseconds), or evidence of acute myocardial
             ischemia

          -  Have serious preexisting medical conditions that, in the judgment of the investigator,
             would preclude participation in this study (for example, history of major surgical
             resection involving the stomach or small bowel)

          -  Have symptomatic central nervous system (CNS) malignancy or metastasis. For
             asymptomatic participants without history of CNS malignancy or metastases

          -  Have evidence or history of a leukemia

          -  Have received a stem-cell transplant. As an exception, a participant with lymphoma who
             received an autologous stem-cell transplant is eligible for the study, if more than 75
             days have passed before the initial dose of study drug

          -  Have active bacterial, fungal, and/or known viral infection (for example, human
             immunodeficiency virus [HIV], hepatitis B, or hepatitis C)