Study of Tesetaxel in Japanese Patients With Solid Tumors

A Phase I Study of Tesetaxel Administered Once Every 21 Days to Japanese Subjects With Advanced Solid Tumors

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.

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