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Study of Tesetaxel in Japanese Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT01337310
Recruitment Status : Unknown
Verified March 2012 by Genta Incorporated.
Recruitment status was:  Recruiting
First Posted : April 18, 2011
Last Update Posted : March 13, 2012
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: Tesetaxel Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : September 2012

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 Name: DJ-927



Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. Percentage of patients with adverse events [ Time Frame: Through 30 days after the last dose of tesetaxel ]
  3. Tumor response rate [ Time Frame: After Cycle 2 (expected to be after Day 42 counting from the date of first dose of tesetaxel) ]


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT01337310     History of Changes
Other Study ID Numbers: TOPK106
First Posted: April 18, 2011    Key Record Dates
Last Update Posted: March 13, 2012
Last Verified: March 2012

Keywords provided by Genta Incorporated:
Advanced solid tumors