A Randomized Placebo-Controlled Study of Perifosine in Combination With Single Agent Chemotherapy for Metastatic Cancer Patients
This is an exploratory phase 2, randomized placebo-controlled trial with stratification for
disease and chemotherapy type. If there is any evidence of improved time to progression in
any tumor type with any of the drugs to be evaluated, the initial study or component(s) of
the study will be expanded to increase the certainty that this is an effect of perifosine.
If there is compelling evidence of benefit from this study, a phase 3 trial will be
conducted to obtain proof of principle.
Primary Study Objectives:
To determine the time to tumor progression when receiving single agent chemotherapy
(capecitabine) in combination with perifosine in comparison to patients receiving single
agent chemotherapy (capecitabine) alone (i.e., with placebo).
Secondary Study Objectives:
- To determine the toxicity of single agent chemotherapy in combination with perifosine.
- To compare the time to progression of chemotherapy in combination with placebo to
historical experience.
- Overall survival will also be evaluated.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
To determine the time to tumor progression.
Every 12 weeks
No
United States: Food and Drug Administration
Perifosine 211
NCT00398879
August 2005
October 2011
Name | Location |
---|---|
AOI Pharmaceuticals Investigative Site | Berkeley, California 94704 |
AOI Pharmaceuticals Investigative Site | Atlanta, Georgia 30322 |
AOI Pharmaceuticals Investigative Site | Chicago, Illinois 60611 |
AOI Pharmaceuticals Investigative Site | Ann Arbor, Michigan 48103 |
AOI Pharmaceuticals Investigative Site | Charlottesville, Virginia 22908 |
AOI Pharmaceuticals Investigative Site | Orlando, Florida 32804 |
AOI Pharmaceuticals Investigative Site | Lexington, Kentucky 40536 |
AOI Pharmaceuticals Investigative Site | Durham, North Carolina 27710 |
AOI Pharmaceuticals Investigative Site | Greenville, South Carolina 29605 |
AOI Pharmaceuticals Investigative Site | Dallas, Texas 75246 |
AOI Pharmaceuticals Investigative Site | Tuscon, Arizona 85704 |
AOI Pharmaceuticals Investigative Site | Colorado Springs, Colorado 80909 |
AOI Pharmaceuticals Investigative Site | Middletown, Connecticut 06457 |
AOI Pharmaceuticals Investigative Site | Lafayette, Louisiana 70506 |
AOI Pharmaceuticals Investigative Site | Branson, Missouri 65616 |
AOI Pharmaceuticals Investigative Site | Billings, Montana 59103 |
AOI Pharmaceuticals Investigative Site | Albany, New York 12208 |
AOI Pharmaceuticals Investigative Site | Dayton, Ohio 45409 |
AOI Pharmaceuticals Investigative Site | Pottsville, Pennsylvania 17901 |
AOI Pharmaceuticals Investigative Site | Chattanooga, Tennessee 37404 |
AOI Pharmaceuticals Investigative Site | Spokane, Washington 99218 |
AOI Pharmaceuticals Investigative Site | Appleton, Wisconsin 54915 |