FAP Clinical Trial for New Drugs

Cancer Prevention Pharmaceuticals recently closed enrollment for a clinical trial that is evaluating a new drug combination (eflornithine (DMFO) and sulindac) for patients with FAP (familial adenomatous polyposis). This study will determine if a combination drug treatment can work better than each drug alone in preventing the disease from getting worse. It will also look to see if this new treatment for FAP can reduce the number and/or size of colon polyps and will look at how the medication might change quality of life.

Status:  Active, not recruiting.



New FAP Drugs Eflornithine (DMFO) and Sulindac

The two drugs used in this study are eflornithine (CPP-1X, also known as DFMO) and sulindac. Sulindac is a drug that is similar to aspirin, naproxen, and ibuprofen in that it blocks inflammation. It has been shown in several studies to reduce the growth of colon polyps, but has not been approved by the FDA for this indication. Eflornithine (CPP-1X) is an experimental drug that has also been shown to reduce the growth of polyps in the colon. Earlier clinical trials have shown that these two drugs work together to reduce the number of colon polyps. A study in patients with a history of large colon polyps showed a dramatic reduction in all colon polyps (more than 70%) and a 92% reduction in advanced polyps (also known as adenomas).

For more detailed information on the study go to ClinicalTrials.gov and search for study NCT01483144.

This section discusses pipeline drug candidates currently undergoing clinical testing. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the indications described in this section.