A Study in Advanced Cancer
Condition: Advanced Cancer
MeSH terms: Neoplasms
Intervention: Taladegib
Intervention description: Administered IV
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Terminal; Solid Tumor; End Stage; Metastatic

Summary:

      The purpose of this study is to find a recommended dose level and schedule of dosing
      LY2940680 that can safely be taken by participants with advanced cancer. The study will also
      explore the changes in a cancer marker level in skin, hair follicles, buccal cells, and tumor
      cells. Finally, the study will help document any antitumor activity this drug may have.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histological or cytological evidence of a diagnosis of cancer that is advanced
             and/or metastatic. The patient must be, in the judgment of the investigator, an
             appropriate candidate for experimental therapy.

          -  Have the presence of measurable or nonmeasurable disease

          -  Have adequate organ function, including:

               -  Hematologic: Absolute neutrophil count (ANC) greater than or equal to 1.5 x
                  109/L, platelets greater than or equal to 100 x 109/L, and hemoglobin greater
                  than or equal to 9 g/dL. Patients may receive erythrocyte transfusions to achieve
                  this hemoglobin level at the discretion of the investigator. Initial treatment
                  must not begin until 5 days after the erythrocyte transfusion.

               -  Hepatic: Bilirubin less than or equal to 1.5 times upper limits of normal (ULN),
                  ALT, and aspartate transferase (AST) less than or equal to 2.0 times ULN. If the
                  liver has tumor involvement AST and ALT equaling less than or equal to 5 times
                  ULN are acceptable.

               -  Renal: Serum creatinine less than or equal to 1.5 times ULN.

          -  Have a performance status of less than or equal to 1 on the Eastern Cooperative
             Oncology Group (ECOG) scale

          -  Have discontinued previous treatments for cancer and recovered from the acute effects
             of therapy (for example, at least 42 days for mitomycin-C or nitrosoureas, 28 days for
             other chemotherapy and biologics. At the discretion of the investigator, hormone
             refractory prostate cancer patients who are stable on gonadotropin-releasing hormone
             (GnRH) agonist therapy and breast cancer patients who are stable on antiestrogen
             therapy (for example, an aromatase inhibitor) may continue treatment

        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 serious preexisting medical conditions

          -  Have symptomatic central nervous system (CNS) malignancy (with the exception of
             medulloblastoma) or metastasis (screening not required). Patients with treated CNS
             metastases are eligible for this study if they are not currently receiving
             corticosteroids and/or anticonvulsants, and their disease is asymptomatic and
             radiographically stable for at least 60 days.

          -  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 (screening is not required)

          -  Have a second primary malignancy that in the judgment of the investigator and sponsor
             may affect the interpretation of results

          -  Have QTc interval of >500 msec on screening electrocardiogram

          -  Patients who have previously received treatment with LY2940680