Tesetaxel as Second-line Therapy for Patients With Advanced Melanoma and Normal Serum LDH
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ClinicalTrials.gov Identifier: NCT01092585
Verified November 2011 by Genta Incorporated. Recruitment status was: Recruiting
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).
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.
Response rate (RECIST) [ Time Frame: 12 months from date of first dose of study medication ]
Secondary Outcome Measures
Proportion of patients with a confirmed complete or partial response at least 3 months in duration [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 12 months from date of first dose of study medication ]
Duration of response [ Time Frame: 12 months from date of first dose of study medication ]
Adverse events [ Time Frame: Through 30 days post last dose of study medication ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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