Study of Tesetaxel in Japanese Patients With Solid Tumors

NCT ID: NCT01337310

Last Updated: 2012-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-09-30

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tesetaxel

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

Group Type: EXPERIMENTAL

Tesetaxel

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

DJ-927

Eligibility Criteria

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

Exclusion Criteria

• Brain metastasis or leptomeningeal disease
• Significant medical disease other than cancer
• Neuropathy greater than Grade 1

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genta Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kinki University School of Medicine

Osaka-fu, , Japan

Site Status: RECRUITING

Countries

Japan

Facility Contacts

Takayasu Kurata, MD, PhD

Role: primary

+81-72-366-0221

Other Identifiers

TOPK106

Identifier Type: -

Identifier Source: org_study_id