Study of Tesetaxel in Japanese Patients With Solid Tumors

NCT01337310 | Unknown Phase 1 DMC

• 1 other identifier: TOPK106
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Advanced solid tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

Study Arms (1)

Tesetaxel

EXPERIMENTAL

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

Drug: Tesetaxel

Interventions

Tesetaxel 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.

Also known as: DJ-927

Tesetaxel

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Genta Incorporated: lead

Study Sites (1)

Kinki University School of Medicine

Osaka-fu, 589-8511, Japan

RECRUITING

MeSH Terms

Interventions

tesetaxel

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 18, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 13, 2012

Record last verified: 2012-03

Locations

JP (1)