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

Phase 2
18 Years
Open (Enrolling)

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Trial Information

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

Inclusion 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (RECIST)

Outcome Time Frame:

12 months from date of first dose of study medication

Safety Issue:


Principal Investigator

Agop Y Bedikian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Texas MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2010

Completion Date:

March 2012

Related Keywords:

  • Melanoma
  • Melanoma



The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009