Allied Health Professionals

Phase III trial of the Safety and Efficacy of CPP-1X/Sulindac Compared with CPP-1X, Sulindac as Single Agents in Patients with Familial Adenomatous Polyposis (FAP)

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This is a multicenter study conducted at FAP registries in North America and Europe.  

Objective: To determine if CPP-1X plus Sulindac increases the time to an “FAP disease related event” as compared to CPP-1X alone or Sulindac alone.

These events include 1) disease progression leading to major surgery involving the colon, rectum, pouch, duodenum and/or 2) clinically important events which includes progression to more advanced duodenal polyposis, cancer or death and/or 3) development of large or pre-cancerous polyps in the rectum/pouch.

Another purpose of the study is to determine the amount of the drugs in  the  blood (pharmacokinetics).  This study will also look to see if there  has been improvement in the disease and if there have been changes to one’s quality of life.   Finally, the study will look at the presence of compounds called polyamines in the diet, from a small piece of bowel  tissue and urine to see if they are a marker for response to treatment.

CPP-1X ( eflornithine HCI) and Sulindac are tablets that in previous clinical trials have shown promise in reducing the risk of developing adenomas in non FAP patients who have polyps removed during colonoscopy.

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