Advanced Solid Tumors
Conditions
Keywords
Advanced solid tumors
Brief summary
Tesetaxel is an orally active tubulin-binding inhibitor of the taxane class. Evaluation of tesetaxel in Japanese patients has been limited. This study is being conducted to determine the maximum tolerated dose and safety of tesetaxel administered orally once every 21 days to Japanese patients.
Interventions
DRUGTesetaxel
The starting dose for the first 3 patients treated will be 24 mg/m2. In the absence of dose-limiting toxicity, the dose will be increased by 3 mg/m2 for the next group of 3 patients treated. Interpatient dose escalation will continue in this manner to 27 and 31 mg/m2 until the maximum tolerated dose or the maximum dose allowed per protocol (31 mg/m2) is reached and 6 patients are treated at this dose.
Sponsors
Genta Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Primary inclusion criteria: * At least 20 years of age * Morphologic or cytologic confirmation of an advanced or metastatic solid tumor malignancy, not to include lymphoma, for which no standard therapy exists or for which resistance or intolerance to standard therapy has developed * ECOG performance status not more than 1 * Adequate bone marrow, hepatic, and renal function * Willing to remain hospitalized for at least 10 days following tesetaxel administration in Cycle 1 * At least 4 weeks and recovery from effects of prior surgery or other therapy with an approved or investigational agent, with resolution of any toxicity to not more than Grade 1 Primary
Exclusion criteria
* Brain metastasis or leptomeningeal disease * Significant medical disease other than cancer * Neuropathy greater than Grade 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose in mg/m2 based on the dose-limiting adverse events that occur | First cycle (expected to be 21 days, including the day of first dose of tesetaxel followed by a rest period) |
Secondary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicities (adverse events that result in a reduction in the dose of tesetaxel in the dose-escalation scheme) | First cycle (expected to be 21 days, including the day of first dose of tesetaxel followed by a rest period) |
| Percentage of patients with adverse events | Through 30 days after the last dose of tesetaxel |
| Tumor response rate | After Cycle 2 (expected to be after Day 42 counting from the date of first dose of tesetaxel) |
Countries
Japan
Outcome results
None listed