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


Phase 1
20 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum tolerated dose in mg/m2 based on the dose-limiting adverse events that occur

Outcome Time Frame:

First cycle (expected to be 21 days, including the day of first dose of tesetaxel followed by a rest period)

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

TOPK106

NCT ID:

NCT01337310

Start Date:

April 2011

Completion Date:

September 2012

Related Keywords:

  • Advanced Solid Tumors
  • Advanced solid tumors
  • Neoplasms

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