Tesetaxel as Second-line Therapy for Patients With Advanced Melanoma and Normal Serum LDH

Primary inclusion criteria:

- Histologically confirmed diagnosis of melanoma

- Progressive disease that is not surgically resectable, or metastatic Stage IV disease

- Measurable disease (revised RECIST; Version 1.1)

- Serum LDH not more than 1.1 times the upper limit of normal

- Eastern Cooperative Oncology Group performance status 0 or 1

- Treatment with 1 prior regimen (including cytotoxic chemotherapy, immunotherapy,
radiation therapy, or cytokine, biologic, or vaccine therapy) as first-line treatment
for metastatic disease (Administration of interleukin-2 or interferon as adjuvant
therapy is allowed and is not to be considered in determining the 1 prior treatment
regimen administered as first-line treatment for metastatic disease.)

- Adequate bone marrow, hepatic, and renal function, as specified in the protocol

- At least 3 weeks and recovery from effects of prior surgery or other therapy with an
approved or investigational agent

- Ability to swallow an oral solid-dosage form of medication

Primary exclusion criteria:

- History or presence of brain metastasis or leptomeningeal disease

- Primary ocular or mucosal melanoma

- Significant medical disease other than cancer

- Organ allograft

- Presence of neuropathy > Grade 1 (National Cancer Institute Common Toxicity Criteria
[NCI CTC]; Version 4.0)

- Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other
than a vinca alkaloid

- Need to continue any regularly-taken medication that is a potent inhibitor or inducer
of the CYP3A pathway or P-glycoprotein activity