The X-PECT phase III clinical trial has finished recruiting over 430 patients, evaluating perifosine treatment for patients with advanced colorectal cancer who have exhausted standard treatments.
The trial compares the effectiveness of adding perifosine to Xeloda® (capecitabine).
Led by Johanna Bendell, M.D., from the Sarah Cannon Research Institute in Nashville, TN, the trial is being conducted at 65 sites in the United States.
X-PECT is randomized and double-blinded. Neither patients or their doctors will know if they are receiving perifosine in combination with Xeloda or a placebo plus Xeloda.
The primary trial endpoint is overall survival time, but it will also be studying complete and partial response rates, time to progression, and side effects. Tissue is being collected to find out if there are biomarkers that might indicate which patients benefit from perifosine treatment.
Perifosine is an oral drug that blocks AKT signalling in the PI3K pathway leading to cancer cell death. Results from a smaller Phase II trial were reported at ASCO in 2010 and showed an improvement over Xeloda alone when perifosine was added.
The X-PECT trial is sponsored by Keryx Biopharmaceuticals, which has been granted the North American license for perifosine by Aeterna Zentaris Inc.
What This Means for Patients
Results from the X-PECT trial are not yet available, although completing enrollment is an important step. It is difficult to predict when we will know if perifosine improves survival time for people who have had cancer get worse on standard treatments.
Perifosine is still an experimental drug and is not on the market.
Fight Colorectal Cancer will watch for more information and report it when it is available.