Tesetaxel is an orally administered chemotherapy agent of the taxane class. This study is being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line therapy to patients with advanced melanoma and normal serum lactate dehydrogenase (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