NCT01337310

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Genta Incorporated · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Tesetaxel	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.

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-07-01
• Completion: 2012-09-01
• First posted: 2011-04-18
• Last updated: 2012-03-13

Locations

1 site across 1 country: Japan