A Phase 2 Study of Marqibo in Patients With Metastatic Uveal Melanoma

Inclusion Criteria:

- Uveal melanoma with histologic or cytologic confirmation of metastatic disease.

- One unidimensionally measurable lesion. If this is a cutaneous lesion it must be at
least 10 mm by caliper measure. If it is a visceral or nodal or soft tissue lesion,
it must be >20 mm with conventional techniques or >10 mm with spiral CT scan. Bone
lesions are not considered measurable.

- Must not have received any prior systemic chemotherapy, immunotherapy, vaccine or
hepatic arterial chemotherapy for metastatic disease.

- Adequate liver, renal, and bone marrow function.

- Zubrod performance status of 0-2.

- Sign an informed consent form.

Exclusion Criteria:

- Major surgery within 4 weeks of enrollment.

- Advanced symptomatic central nervous system (CNS) involvement by melanoma and those
on phenytoin or requiring steroids for brain metastases, spinal cord compression, or
meningeal "carcinomatosis".

- History of neurological disorders unrelated to chemotherapy (including familial
neurological diseases and acquired demyelinating disorders).

- Grade 2 or greater sensory, motor and/or autonomic neuropathy at screening from any
cause.

- Receiving treatment with drugs known to inhibit or induce hepatic drug metabolism by
cytochrome P450-3A4 isoenzymes and/or P-glycoprotein within 1 week of study
enrollment.