- Have histological or cytological evidence of a diagnosis of advanced and/or
metastatic cancer (solid tumors) that is refractory to standard therapy and/or
therapies known to provide clinical benefit, or for which no standard therapy exists.
- Have the presence of disease amenable to efficacy assessment as defined by the
Response Evaluation Criteria In Solid Tumors(RECIST). Japanese patients who have
advanced non-measurable disease with elevation of a validated tumor marker may be
eligible, if discussed and agreed upon by the investigator and Lilly.
- 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(transfusions are not allowed prior to enrollment within
- Hepatic: Bilirubin less than or equal to 1.5 times upper limit of normal
(ULN),alkaline phosphatase (ALP), alanine transaminase (ALT) and aspartate
transaminase (AST) less than or equal to 2.5 times ULN, or 5 times ULN for
patients with hepatic metastases. Patients with bone metastases may enter with
alkaline phosphatase values less than 5 times ULN, as long as other hepatic
parameters meet inclusion criteria.
- Renal: Serum creatinine less than or equal to 1.5 times ULN.
- Have a performance status of less than or equal to 2 on the Eastern Cooperative
Oncology Group scale
- Have discontinued all previous therapies for cancer, including chemotherapy,
radiotherapy, cancer-related hormonal therapy prior to study enrollment and recovered
from the acute effects of therapy.
- Have an estimated life expectancy of 12 weeks or greater
- Are able to swallow capsules
- Have received treatment within 4 weeks of the initial dose of study drug with a drug
that has not received regulatory approval for any indication.
- Have serious preexisting medical conditions or serious concomitant systemic disorders
that, in the opinion of the investigator, would preclude participation in this study.
- Prior clinical history of tuberculosis (patient doubt tuberculosis is screening
required), and positive test results in hepatitis B surface antigen (HBSAg), or
hepatitis C antibodies (HCAb) (screening required).
- Have symptomatic central nervous system (CNS) malignancy or metastasis. Patients with
treated CNS metastases are eligible provided their disease is radiographically
stable, asymptomatic, and they are not currently receiving corticosteroids and/or
anticonvulsants. Screening of asymptomatic patients without history of CNS metastasis
is not required.
- Have hematologic malignancies, or lymphoma.