A Phase II Study of LBH589 in the Treatment of Patients With Refractory Clear Cell Renal Carcinoma

Inclusion Criteria:

- Histologically documented metastatic or locally unresectable clear cell renal
carcinoma. In patients with mixed histologies, the clear cell component must
comprise > 75% of the cancer.

- Documented disease progression or intolerance while receiving treatment with: a)
sunitinib, sorafenib, or both, and b) temsirolimus.

- Maximum of 4 prior systemic regimens allowed and may include other targeted agents,
immunotherapy and chemotherapy.

- Measurable disease by RECIST criteria.

- ECOG PS 0 or 1.

- Laboratory values as follows: ANC >= 1500/μL, Hgb >= 9 g/dL, Platelets >= 100,000/uL,
AST/SGOT and ALT/SGPT <= 2.5 x ULN or <= 5.0 x ULN in patients with liver metastases,
Creatinine <= 2.0 mg/dL Or Calculated Creatinine Clearance >= 50 ml/min, Albumin >= 3
g/dL, Potassium >= lower limit normal (LLN),Phosphorous >= LLN, Calcium >= LLN,
Magnesium > LLN

- Women of childbearing potential must have a negative serum or urine pregnancy test
performed within 7 days prior to start of treatment.

- Life expectancy > 12 weeks.

- Accessible for treatment and follow-up.

- All patients must be able to understand the nature of the study and give written
informed consent prior to study entry.

Exclusion Criteria:

- Age < 18 years of age.

- Prior treatment with an HDAC inhibitor.

- Impaired cardiac function

- Ongoing therapy with antiarrhythmics or other medications associated with QTc
prolongation.

- Uncorrected hypokalemia or hypomagnesemia.

- Uncontrolled hypertension or cardiac arrhythmias.

- Active parenchymal brain metastases. Patients who have had brain metastases
resected, or have received radiation therapy ending > 8 weeks prior to study entry
are eligible if they meet all of the following criteria: 1) residual neurologic
symptoms < grade 1, 2) no dexamethasone requirement, 3) follow-up MRI shows
regression of lesions after treatment, with no new lesions appearing.

- Active meningeal metastases.

- Known diagnosis of human immunodeficiency virus (HIV) infection.

- Unresolved diarrhea > CTCAE grade 1.

- Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors.

- Chemotherapy, investigational drug therapy, major surgery < 4 weeks prior to starting
study drug or patients that have not recovered from side effects of previous therapy.

- Patient is < 5 years free of another primary malignancy except if the other primary
malignancy is not currently clinically significant or requiring active intervention,
or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in
situ. Existence of any other malignant disease is not allowed.

- Concomitant use of any anti-cancer therapy or radiation therapy.

- Pregnant or breast feeding or female of reproductive potential not using 2 effective
methods of birth control.

- Male patients whose sexual partners are women of childbearing potential not using
effective birth control.

- Patients with gastrointestinal (GI) tract disease, causing the inability to take oral
medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation,
prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease.

- Other concurrent severe, uncontrolled infection or intercurrent illness

- Abnormal thyroid function (TSH or free T4) detected at screening. Patients with
known hypothyroidism who are stable on thyroid replacement are eligible.