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

Genta Incorporated

Status and phase

Unknown

Phase 2

Conditions

Melanoma

Treatments

Drug: Tesetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT01092585

TOM202

Details and patient eligibility

About

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).

Enrollment

27 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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