Perifosine was no better than a placebo in improving survival time for people with late-stage colorectal cancer according to a news release from Keryx Biopharmaceuticals.

Despite success in a smaller Phase II clinical trial, the X-PECT Phase III trial failed to meet its primary objective — longer survival time.

X-PECT randomized 468 patients to receive either:

• Xeloda® (capecitabine) plus perifosine, or
• Xeloda plus a placebo

Although final details were not provided, the perifosine group did not live longer than the patients who got a dummy pill.

Patients in the trial had refractory colorectal cancer, tumors that had already gotten worse on at least two standard chemotherapy regimens. Had perifosine helped increase survival time, it would have been a significant new treatment for patients who have exhausted all their standard treatment options.

Based on these results, Keryx will not be pursuing FDA approval for perifosine for refractory colorectal cancer.

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. Read the rest of this entry »

At ASCO in June 2009  a study was presented showing potential benefit of a novel inhibitor of AKT and MAPK in patients with metastatic colon cancer in second and third line chemotherapy.  An update at the 2010 ASCO GI meeting in January further confirmed these promising results.

This was a randomized phase II study comparing Xeloda alone versus a combination of Perifosine and Xeloda. Read the rest of this entry »