A Study of Abemaciclib (LY2835219) in Native Chinese Participants With Advanced and/or Metastatic Cancers
Condition: Advanced Cancer; Metastatic Cancer
MeSH terms: Neoplasm Metastasis; Neoplasms; Neoplasms, Second Primary
Intervention: Abemaciclib
Intervention description: Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CDK4/6 Inhibitor

Summary:

      The purpose of this study is to determine the safety of the study drug known as abemaciclib
      in native Chinese participants with advanced and/or metastatic cancers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant must have histological or cytological evidence of cancer which is
             advanced and/or metastatic, and is an appropriate candidate for experimental therapy
             in the judgment of the investigator, after available standard therapies have ceased to
             provide clinical benefit.

          -  Have the presence of measureable disease as defined by the Response Evaluation
             Criteria in Solid Tumors (RECIST 1.1).

          -  Are native Chinese men or women.

          -  Have adequate organ function, including:

               -  Hematologic: Absolute neutrophil count (ANC) ≥1.5 x 109/Liters (L), platelets
                  ≥100 x 109/L, and hemoglobin ≥9 grams per deciliter. Participants may receive
                  erythrocyte transfusions to achieve this hemoglobin level or platelet
                  transfusions to achieve platelet levels at the discretion of the investigator;
                  however, initial study drug treatment must not begin earlier than the day after
                  transfusion.

               -  Hepatic: Bilirubin ≤1.5 times upper limits of normal (ULN), alanine
                  aminotransferase (ALT), and aspartate aminotransferase (AST) ≤3.0 times ULN.

               -  Renal: Serum creatinine ≤1.2 milligrams per deciliter (mg/dL) for males or ≤1.0
                  mg/dL for females.

          -  Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.

          -  Recovered from the acute effects of therapy (treatment- related toxicity resolved to
             baseline) except for residual alopecia.

          -  Have an estimated life expectancy of ≥12 weeks.

        Exclusion Criteria:

          -  Have received previous therapies for cancer (including chemotherapy, radiotherapy,
             immunotherapy, and investigational therapy) within 21 days for myelosuppressive agents
             or 14 days for nonmyelosuppressive agents prior to receiving study drug.

          -  Have an acute leukemia or other relevant cancers at the discretion of the
             investigator.

          -  Females who are pregnant or lactating.

          -  Participants consuming drugs or foods that are known to be inducers (for example,
             grapefruit juice, phenytoin, carbamazepine) or strong inhibitors of CYP3A4 should be
             excluded during Cycle 1.

          -  Have history or evidence of central nervous system (CNS) malignancy or metastasis.
             Screening of asymptomatic participants without history of CNS metastases is not
             required for enrollment.