A Study of LY2940680 in Japanese Participants With Advanced Cancers
Condition: Neoplasm Metastasis
MeSH terms: Neoplasm Metastasis
Intervention: LY2940680
Intervention description: Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to assess the safety and tolerability of LY2940680 up to
      the global recommended dose in Japanese participants with advanced solid cancers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histological or cytological evidence of a diagnosis of solid tumor that is
             advanced and/or metastatic. The participant 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 nonmeasurable disease as defined by the Response
             Evaluation Criteria in Solid Tumors Guideline Version 1.1

          -  Have adequate organ function

          -  Have discontinued all previous therapies for cancer, including chemotherapy,
             radiotherapy, cancer-related hormonal therapy for at least 3 weeks (6 weeks for
             mitomycin-C or nitrosoureas, 2 weeks for palliative radiation therapy for bone
             metastasis) prior to study enrollment, and have recovered from the acute effects of
             any such therapy

          -  Males must agree to use medically approved barrier contraceptive precautions during
             the study and for 6 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 6 months following the last dose of
             study drug; have had a negative serum 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 6 months after the last administration

          -  Have an estimated life expectancy, in the judgment of the investigator, which will
             permit the participant to complete 2 cycles of treatment

          -  Are able to swallow tablets

        Exclusion Criteria:

          -  Have received treatment within 21 days of the study enrollment with any agent that has
             not received regulatory approval for any indication

          -  Have symptomatic central nervous system (CNS) malignancy or metastasis. Participants
             with treated brain metastases are eligible if they are clinically stable with regard
             to neurologic function and off steroids after cranial irradiation ending at least 14
             days prior to enrollment, or after surgical resection performed at least 28 days prior
             to enrollment

          -  Have known current hematologic malignancies or acute or chronic leukemia

          -  Have a known active fungal, bacterial, and/or known viral infection including human
             immunodeficiency (HIV) or viral (A, B, or C) hepatitis, potentially affecting the
             conduct of this study

          -  Have a second primary malignancy that in the judgment of the investigator and sponsor
             may affect the interpretation of results

          -  Have QTc interval of >470 milliseconds (msec) on screening electrocardiogram (ECG)

          -  Have serious preexisting medical conditions or serious concomitant systemic disorders
             that, in the opinion of the investigator, would preclude participation in this study

          -  Have received any medication that is a strong inhibitor of cytochrome P4503A4 (CYP3A4)
             within 7 days prior to receiving study drug