A Phase 1b Study of LY573636-sodium in Combination With Sunitinib Malate in Patients With Metastatic Renal Cell Cancer

Inclusion Criteria:

- Patients must have a histologically confirmed diagnosis of metastatic RCC

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

- Patients 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 g/L

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

- Exhibit patient 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). Patients 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 msec for males or greater than 470 msec for
females

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

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

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

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

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

- Patients who have previously completed or withdrawn from this study or any other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

- Patients who have previously received sunitinib

- Patients who are unable to swallow capsules

- Patients who require concomitant use of potent CYP3A4 inducers or inhibitors

- Women who are pregnant or lactating