Study of Tesetaxel in Japanese Patients With Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Phase I Study of Tesetaxel Administered Once Every 21 Days to Japanese Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01337310
• Other study ID #: TOPK106
• Status: Recruiting
• Phase: Phase 1
• First received: April 4, 2011
• Last updated: March 11, 2012
• Start date: April 2011
• Est. completion date: September 2012

Study information

• Verified date: March 2012
• Source: Genta Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: September 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

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.

Locations

Country	Name	City	State
Japan	Kinki University School of Medicine	Osaka-fu

Sponsors (1)

Lead Sponsor	Collaborator
Genta Incorporated

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	Yes
Secondary	Percentage of patients with adverse events		Through 30 days after the last dose of tesetaxel	Yes
Secondary	Tumor response rate		After Cycle 2 (expected to be after Day 42 counting from the date of first dose of tesetaxel)	No