A Phase 1b Trial in Patients With Renal Cell Cancer

Inclusion Criteria:

- Participants must have a histologically confirmed diagnosis of metastatic Renal Cell
Carcinoma (RCC)

- Participants must have received no prior treatment with a cytotoxic-based chemotherapy
regimen

- Participants must have measurable disease as defined by the Response Evaluation
Criteria in Solid Tumors (RECIST) guidelines

- Have adequate hematologic, hepatic and renal function

- Have a serum albumin level greater than equal to 3.0 grams/Liter (g/L)

- Participants with reproductive potential should use medically approved contraceptive
precautions during the trial and for 6 months following the last dose of study drug

- Exhibit participant compliance and geographic proximity that allow for adequate
follow-up

- Have given written informed consent approved by Lilly and the ethical review board
(ERB)/institutional review board (IRB) governing the site

- Have discontinued all previous therapies for cancer, including chemotherapy,
radiotherapy, cancer-related hormonal therapy, or other investigational therapy, for
at least 4 weeks (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment
and recovered from the acute effects of therapy (except alopecia). Participants who
have received whole-brain radiation must wait 90 days before starting study therapy

Exclusion Criteria:

- Have received treatment within the last 30 days with a drug that has not received
regulatory approval for any indication at the time of study entry

- Have received a prior cytotoxic chemotherapy-based systemic therapy for metastatic RCC

- Have had any of the following within 12 months prior to study drug administration:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, congestive heart failure (CHF), cerebrovascular accident, transient ischemic
attack, or pulmonary embolism

- Ongoing cardiac arrhythmias greater than New York Health Association Class II
(Protocol Attachment JZAI.4), atrial fibrillation of any grade, or prolongation of the
QTc interval to greater than 450 milliseconds (msec) for males or greater than 470
msec for females

- Have uncontrolled hypertension [greater than 150/100 millimeters of mercury (mm Hg)
despite optimal medical therapy], or history of poor compliance with antihypertensive
treatment

- Participants with documented central nervous system or leptomeningeal metastasis
(brain metastasis) at the time of study entry. Participants with signs or symptoms of
neurological compromise should have appropriate radiographic imaging performed before
study entry

- Participants with serious concomitant OR pre-existing disorders, including active
bacterial, fungal, or viral infection, incompatible with the study (at the discretion
of the investigator)

- Participants receiving warfarin therapy for treatment of venous thrombosis or other
prothrombotic conditions

- Participants with a second primary malignancy that could affect interpretation of the
results. NOTE: Participants with adequately treated carcinoma of the skin (excluding
melanoma) and participants with a prior history of malignancy who have been
disease-free for greater than 2 years are eligible

- Participants who have previously completed or withdrawn from this study or any other
study investigating LY573636

- Participants who have previously received sunitinib

- Participants who are unable to swallow capsules

- Participants who require concomitant use of potent Cytochrome P450 3A4 (CYP3A4)
inducers or inhibitors

- Women who are pregnant or lactating