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

• Status: Unknown status
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genta Incorporated

Criteria

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