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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
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.
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGResponse rate (RECIST)
Time frame: 12 months from date of first dose of study medication
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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