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Study of Tesetaxel in Japanese Patients With Solid Tumors

This study is currently recruiting participants.
Verified March 2012 by Genta Incorporated
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT01337310
First received: April 4, 2011
Last updated: March 11, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Advanced Solid Tumors
 Drug: Tesetaxel
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Tesetaxel Administered Once Every 21 Days to Japanese Subjects With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Genta Incorporated:

Primary Outcome Measures:
  • Maximum tolerated dose in mg/m2 based on the dose-limiting adverse events that occur [ Time Frame: First cycle (expected to be 21 days, including the day of first dose of tesetaxel followed by a rest period) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Dose-limiting toxicities (adverse events that result in a reduction in the dose of tesetaxel in the dose-escalation scheme) [ Time Frame: First cycle (expected to be 21 days, including the day of first dose of tesetaxel followed by a rest period) ] [ Designated as safety issue: Yes ]
  • Percentage of patients with adverse events [ Time Frame: Through 30 days after the last dose of tesetaxel ] [ Designated as safety issue: Yes ]
  • Tumor response rate [ Time Frame: After Cycle 2 (expected to be after Day 42 counting from the date of first dose of tesetaxel) ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: April 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: DJ-927

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337310

Locations
Japan
Kinki University School of Medicine Recruiting
Osaka-fu, Japan, 589-8511
Contact: Takayasu Kurata, MD, PhD     +81-72-366-0221        
Principal Investigator: Takayasu Kurata, MD, PhD            
Sponsors and Collaborators
Genta Incorporated
  More Information

No publications provided

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT01337310     History of Changes
Other Study ID Numbers: TOPK106
Study First Received: April 4, 2011
Last Updated: March 11, 2012
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Genta Incorporated:
Advanced solid tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013