Study of Tesetaxel in Japanese Patients With Solid Tumors

Phase 1

• Conditions: Advanced Solid Tumors
• Interventions: Drug: Tesetaxel

• Registration Number: NCT01337310
• Lead Sponsor: Genta Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-04-15
• Study First Posted: 2011-04-18
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-11
• Last Update Posted: 2012-03-13
• Primary Completion: 2012-07
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tesetaxel	Tesetaxel	Tesetaxel administered orally once every 21 days for at least 2 cycles

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Kinki University School of Medicine; 🇯🇵 Osaka-fu, Japan