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A Phase I Study of Tesetaxel Administered in Combination With Capecitabine to Subjects With Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Solid Tumor

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Trial Information

A Phase I Study of Tesetaxel Administered in Combination With Capecitabine to Subjects With Solid Tumors

Inclusion Criteria:

- At least 18 years of age

- Confirmed diagnosis of a solid tumor malignancy, excluding lymphoma

- Chemotherapy-naïve or previously treated with not more than 1 non-taxane-containing
chemotherapy (Enrollment of patients with a history of prior taxane therapy in the
adjuvant setting is allowed provided at least 6 months have passed since the
conclusion of that therapy.)

- ECOG performance status of 0 or 1

- Adequate bone marrow, hepatic, and renal function

- At least 3 weeks and recovery from effects of prior surgery and anticancer therapy,
with resolution of any toxicity to not more than Grade 1

Exclusion Criteria:

- Brain metastasis or leptomeningeal disease

- Second cancer (except for adequately treated basal cell or squamous cell skin cancer,
in situ cervical cancer, or other cancer for which patient has been disease-free for
5 or more years)

- Known history of human immunodeficiency virus infection or hepatitis B or hepatitis C

- Recurrent diarrhea, defined as more than 3 episodes than is usual in any 24-hour
period within the 30 days prior to enrollment in this study

- Significant medical disease other than cancer

- Neuropathy at least Grade 2

- Difficulty swallowing

- Malabsorptive disorder

- Need for other anticancer treatment while receiving study medication

- Need to continue any regularly-taken medication that is a potent inhibitor or inducer
of the CYP3A pathway or P-glycoprotein activity. A washout period of at least 2 weeks
is required prior to the first dose of study medication.

- Pregnancy or lactation

- History of hypersensitivity to tesetaxel, capecitabine, 5-fluorouracil, or any of
their components

Type of Study:


Study Design:

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

Outcome Measure:

Incidence of adverse events

Outcome Description:

Percentage of subjects with adverse events

Outcome Time Frame:

Through 30 days following the last dose of study medication

Safety Issue:


Principal Investigator

Lee S Schwartzberg, MD, FACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

The West Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

March 2011

Completion Date:

October 2012

Related Keywords:

  • Solid Tumor
  • Solid tumor malignancy, excluding lymphoma
  • Neoplasms



The West Clinic Memphis, Tennessee  38120