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An Open-label, Single-dose, Randomized, Crossover Study to Determine the Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsule in Solid Tumor Cancer Subjects

Phase 1
18 Years
75 Years
Not Enrolling
Solid Tumors

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Trial Information

An Open-label, Single-dose, Randomized, Crossover Study to Determine the Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsule in Solid Tumor Cancer Subjects

This study is being conducted to determine whether the pharmacokinetics of a single dose of
tesetaxel administered as a capsule is affected by co-administration with food (a high-fat

Inclusion Criteria

Key inclusion criteria:

1. Male or female subjects between 18 and 75 years of age.

2. Histologically or cytologically confirmed advanced solid tumor malignancy.

3. Negative serum pregnancy test within 7 days prior to the first dose of study drug in
women of childbearing potential.

4. Agreement to use a highly effective form of contraception throughout the treatment
phase of the study in women of childbearing potential and sexually active men.

5. Body weight ≥ 50 kg for women and men and BMI within the range of 19 to 35 kg/m2

6. 12-lead ECG without any clinically significant abnormality as judged by the

7. Able to swallow oral medication.

8. Adequate organ system function.

Key exclusion criteria:

1. A positive pre-study hepatitis B surface antigen.

2. Symptomatic or acute hepatic or biliary abnormalities.

3. Clinically significant gastrointestinal abnormalities that increase the risk for

4. Presence of uncontrolled infection.

5. Positive pre-study drug/alcohol screen.

6. Treatment with an investigational agent within the following time periods prior to
the first dose of study drug: 30 days, 5 half-lives, or twice the duration of the
biological effect of the investigational product (whichever is longest).

7. Current treatment with any cancer therapy that is causing significant
gastrointestinal side effects, including but not limited to, nausea, vomiting, and

8. Any serious and/or unstable pre-existing medical, psychiatric, or other condition
that could interfere with a subject's safety, obtaining informed consent, or
compliance with the study.

9. Pregnancy or lactation.

10. Hypoalbuminemia (serum albumin <3.0 g/dL) at screening.

11. Consumption of red wine, seville oranges, grapefruit or grapefruit juice, and/or
pummelos, exotic citrus fruits, or grapefruit hybrids within 14 days prior to the
first dose of study drug.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Outcome Measure:

Pharmacokinetic parameters

Outcome Description:

Pharmacokinetic parameters include the area under the blood concentration-time curve (AUC0-inf, AUC0-t), concentration 24 h post dose (C24), maximum blood concentration (Cmax), time to maximum blood concentration (Tmax), terminal half-life (t½), and oral clearance (CL/F)

Outcome Time Frame:

Predose and postdosing up to 36 days after administration of each dose

Safety Issue:


Principal Investigator

Harry W Alcorn, PharmD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Davita Clinical Research


United States: Food and Drug Administration

Study ID:




Start Date:

June 2010

Completion Date:

April 2011

Related Keywords:

  • Solid Tumors
  • Advanced solid tumors
  • Neoplasms



DaVita Clinical Researh Minneapolis, Minnesota  55404