Melanoma
Conditions
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).
Interventions
DRUGTesetaxel
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.
Sponsors
Genta Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (RECIST) | 12 months from date of first dose of study medication |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed