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

A Phase II Study of Tesetaxel as Second-line Therapy for Subjects With Advanced Melanoma and Normal Serum LDH

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