A Phase II Trial of TPI 287 in Patients With Metastatic Prostate Cancer Who Have Progressive Neoplastic Disease Following Treatment With One Prior Taxane Regimen
This is an open-label, multi-center, 2-stage Simon design, Phase 2 study of TPI 287 in
patients with metastatic, hormone-refractory prostate cancer. All patients must have
received prior taxane therapy. Up to 80 patients will be enrolled and stratified based on
duration of cumulative exposure to a single prior taxane regimen. A single taxane regimen is
considered to he a taxane or taxane containing therapy administered on a defined schedule
with no more than 2 months' interruption between treatments, and total exposure will be
assessed by the number of months on that schedule.
One stratum (up to 40 patients) will consist of patients who have had over 3 months (up to a
maximum of 10 months) exposure to a taxane regimen, who then have documented progression of
disease (initially taxane sensitive). The second stratum (up to 40 patients) will consist of
patients considered primarily resistant to taxanes who have had documented progressive
disease as best response after exposure to a single taxane regimen for less than or equal to
3 months. Patients may have received prior hormonal therapy and/or bisphosphonates and may
continue on these therapies.
In the first stage of the trial, 22 patients in each stratum will be treated with TPI 287
intravenously every 21 days. If 1 or fewer patients in either stratum demonstrate a response
in this first stage, the trial will be discontinued for that stratum. Otherwise, an
additional 18 patients in the stratum showing 2 or more responses will be enrolled in the
second stage of the study. If 4 or fewer patients demonstrate a response in the total study
population in either stratum from stages 1 and 2, then the drug will not be considered of
interest in prostate cancer for patients as defined in that stratum.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Sandra Silberman, MD, PhD
Archer Biosciences, Inc.
United States: Food and Drug Administration
|Cedars-Sinai Medical Center||Los Angeles, California 90048|
|St. Barnabas Medical Center||Livingston, New Jersey 07039|
|University of Kentucky||Lexington, Kentucky 40536-0098|
|Tennessee Oncology, PLLC||Clarksville, Tennessee 37043|
|Comprehensive Cancer Center at Desert Mountain||Palm Springs, California 92262|
|Kansas City Cancer Center South||Kansas City, Missouri 64131|