LCI-GU-BLA-SPEC-001: Aurora Kinase Expression in Muscle-Invasive Bladder Cancer

Subjects will receive neoadjuvant cisplatin-based chemotherapy followed by radical
cystectomy per standard of care. CTC and Aurora kinase expression patterns will be analyzed
in subject specimens for correlation with clinicopathologic outcome. Subjects will be on
study for a total of five years following cystectomy.

Inclusion Criteria

- Histologically confirmed American Joint Committee on Cancer seventh edition clinical
stage T2-4a N0-3 urothelial carcinoma of the bladder based on diagnostic
transurethral bladder biopsy or transurethral resection of bladder tumor (TURBT)
confirming the presence of urothelial carcinoma with muscularis propria invasion.

- Archived tissue from prior biopsy/resection must be available for baseline AK
analysis.

- Subjects must be eligible to undergo radical cystectomy and cisplatin-based
chemotherapy.

- Subjects with radiographically enlarged lymph nodes (short axis >10 mm with CT scan
or MRI) should undergo percutaneous biopsy for staging in accordance with local
practices, though preferred, is not mandatory for study enrollment.

- A baseline computed tomography (CT) scan with intravenous contrast of the chest,
abdomen and pelvis is required in all subjects. A radionuclide bone scan is also
required in subjects with skeletal pain or abnormally elevated alkaline phosphatase
values.

- Age at least 18 years old.

- ECOG performance status of 0 or 1.

- Bilirubin less than 1.5 mg/dL.

- Subjects must have adequate liver function: AST and ALT less than 2.5x upper limit of
normal, alkaline phosphatase less than 2.5x upper limit of normal.

- Subjects must have adequate bone marrow function: Platelets greater than 100,000
cells/mm3, Hemoglobin greater than 9.0g/dL and ANC greater than 1,500 cells/mm3.

- Subjects must have adequate renal function with creatinine clearance of at least 60
mL/min.

- Subjects must sign a written informed consent document and authorization for release
of their medical records for the purposes of research.

Exclusion Criteria

- Pure non-urothelial or mixed small cell histology identified within TURBT specimen.

- Absence of documented urothelial carcinoma with muscularis propria invasion on
diagnostic transurethral bladder biopsy or transurethral resection of bladder tumor
(TURBT).

- Distant metastatic disease, including non-regional lymphadenopathy and visceral
metastases, identified on pretreatment radiographic studies.

- Creatinine clearance less than 60 mL/min.

- CTCAE version 4 grade 2 or greater hearing loss.

- CTCAE version 4 grade 2 or greater peripheral neuropathy.

- NYHA class III heart failure or cardiac ejection fraction less than or equal to 50%.

- Women of child-bearing age who are pregnant or breast feeding.

- Uncontrolled and current illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Subjects with other active malignancies as defined as synchronous malignancy at the
time of bladder cancer diagnosis, excluding non-metastatic, non-melanoma skin cancer
are excluded.

- Major surgery within 4 weeks of consent.

- Subjects requiring therapeutic anticoagulation at the time of consent.

- Currently enrolled on another clinical trial for the treatment of bladder cancer.