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

NCT ID: NCT01092585

Last Updated: 2011-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-03-31

Brief 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).

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Tesetaxel

Tesetaxel capsules will be administered orally once every 21 days until the patient meets a withdrawal criterion or initiates nonstudy therapy for melanoma. The duration of protocol therapy will not exceed 12 months.

In Cycle 1, a flat dose of 40 mg will be administered to patients of relatively normal weight. For patients who weigh at least 25% below their ideal body weight, a flat dose of 35 mg will be administered. For patients who weigh at least 25% above their ideal body weight, a flat dose of 45 mg will be administered. Dose escalation by 5 mg in Cycle 2 and an additional 5 mg in Cycle 3 is permitted provided protocol-specified criteria are met.

Intervention Type: DRUG

Other Intervention Names

DJ-927

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genta Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agop Y Bedikian, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas MD Anderson Cancer Center

Locations

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Karen Woodard

Role: primary

KLWoodard@mdanderson.org

Other Identifiers

TOM202

Identifier Type: -

Identifier Source: org_study_id