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

Study Overview
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Brief Summary
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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).

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

Conditions
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Melanoma

Intervention / Treatment
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* Drug: Tesetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (RECIST) |  | 12 months from date of first dose of study medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |