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.

Study Overview

• Status: Unknown
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: Tesetaxel

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Osaka-fu, Japan, 589-8511
    • Recruiting
    • Kinki University School of Medicine
    • Contact: Takayasu Kurata, MD, PhD; Phone Number: +81-72-366-0221
    • Principal Investigator: Takayasu Kurata, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.; Other Names: DJ-927

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Genta Incorporated

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): July 1, 2012
• Study Completion (Anticipated): September 1, 2012

Study Registration Dates

• First Submitted: April 4, 2011
• First Submitted That Met QC Criteria: April 15, 2011
• First Posted (Estimate): April 18, 2011

Study Record Updates

• Last Update Posted (Estimate): March 13, 2012
• Last Update Submitted That Met QC Criteria: March 11, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Advanced solid tumors
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: TOPK106