A Study in Patients With Advanced or Metastatic Cancer
A Study in Patients With Advanced or Metastatic Cancer
Study JWAA is a multicenter, nonrandomized, open-label, dose-escalation Phase 1 study of oral
 LY2780301 in patients with advanced solid tumors.
JWAA will consist of the following treatment phases parts:

 Part A - Dose escalation phase using a once-daily dosing schedule. Part B - Dose escalation
 phase using a twice-daily dosing schedule. Part C - Dose expansion phase using the maximum
 tolerated dose from either Part A or Part B.
Inclusion Criteria:

 -  Have histological or cytological evidence of a diagnosis of cancer that is advanced
 and/or metastatic (including Non-Hodgkin's Lymphoma). The patient must be, in the
 judgment of the investigator, an appropriate candidate for 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 (RECIST 1.1) or the Revised Response Criteria for
 Malignant Lymphoma.

 Parts A and B: have measurable or nonmeasurable disease. Part C: have measurable 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 8 g/dL. Transfusions are not allowed to reach 8 g/dL prior to
 enrollment.

 -  Hepatic: Bilirubin less than or equal to 1.5 times upper limits of normal (ULN),
 alanine aminotransaminase (ALT), and aspartate aminotransaminase (AST) less than
 or equal to 2.5 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 or calculated
 creatinine clearance greater than 45 ml/mn.

 -  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: at least 28 days for myelosuppressive agents or 14 days for
 nonmyelosuppressive agents. At the discretion of the investigator, hormone-refractory
 prostate cancer patients who are stable on gonadotropin-releasing hormone (GnRH)
 agonist therapy may have that treatment continued while they are enrolled in this
 study.

 Exclusion Criteria:

 -  Have received treatment within 28 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 (left to the discretion of the
 investigator).

 -  Have symptomatic central nervous system (CNS) malignancy 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 current acute or chronic leukemia.

 -  Have an active fungal, bacterial, and/or known viral infection including human
 immunodeficiency virus (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 >470 msec on screening electrocardiogram(ECG).

 -  Treatment with a strong CYP3A4 substrate with narrow therapeutic range, strong
 inhibitor, or inducer.

 -  Have history of pituitary adenoma.