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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01092585
• Other study ID #: TOM202
• Status: Recruiting
• Phase: Phase 2
• First received: March 23, 2010
• Last updated: November 4, 2011
• Start date: February 2010
• Est. completion date: March 2012

Study information

• Verified date: November 2011
• Source: Genta Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Genta Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate (RECIST)		12 months from date of first dose of study medication	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Duration of response		12 months from date of first dose of study medication	No
Secondary	Adverse events		Through 30 days post last dose of study medication	Yes