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

NCT01092585 | Unknown Phase 2

• 1 other identifier: TOM202
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Response rate (RECIST)

  12 months from date of first dose of study medication

Secondary Outcomes (5)

• Proportion of patients with a confirmed complete or partial response at least 3 months in duration

  12 months from date of first dose of study medication

• Disease control rate (ie, the proportion of patients with a confirmed complete or partial response of any duration or stable disease at least 3 months in duration)

  12 months from date of first dose of study medication

• Durable response rate (ie, the proportion of patients with a confirmed complete or partial response at least 6 months in duration)

  12 months from date of first dose of study medication

• Duration of response

  12 months from date of first dose of study medication

• Adverse events

  Through 30 days post last dose of study medication

Interventions

Tesetaxel DRUG

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.

Also known as: DJ-927

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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

Sponsors & Collaborators

• Genta Incorporated: lead

Study Sites (1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

tesetaxel

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Agop Y Bedikian, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: March 25, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: November 8, 2011

Record last verified: 2011-11

Locations

US (1)