Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Tesetaxel in Japanese Patients With Solid Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Genta Incorporated.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Genta Incorporated Identifier:
First received: April 4, 2011
Last updated: March 11, 2012
Last verified: March 2012

April 4, 2011
March 11, 2012
April 2011
July 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01337310 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
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.

Not Provided
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors
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
Experimental: Tesetaxel
Tesetaxel administered orally once every 21 days for at least 2 cycles
Intervention: Drug: Tesetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2012
July 2012   (final data collection date for primary outcome measure)

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
20 Years and older
Genta Incorporated
Genta Incorporated
Not Provided
Not Provided
Genta Incorporated
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP