Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genta Incorporated
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
