About CPN Trials

CPN coordinates Phase 0, Phase I, and Phase II clinical trials designed to prevent cancers of the breast, colon, esophagus, kidney, liver, lung, prostate, rectum, and skin. The purpose of a clinical trial is to determine the effectiveness and safety of different chemoprevention strategies.

A Phase 0 study or Exploratory clinical trial is designed to assess the feasibility of pursuing clinical development of an investigational drug. This is a new concept, and the intentions are to provide an early screen of potential drugs and make quicker decisions as to which drugs to continue with clinical development.

Phase I chemoprevention trials are usually conducted in a small number of healthy participants to determine the best dose related to safety, agent effectiveness, and agent pharmacokinetic factors including absorption, distribution, metabolism, and excretion.

Phase II chemoprevention trials are conducted in larger groups of participants who are otherwise healthy but at risk for certain cancers to evaluate agent effectiveness in these individuals. Important objectives include identifying and validating biomarkers, signals to look for, as surrogate endpoints for cancer incidence.

CPN has completed eight clinical trials, studying potential drugs that may provide some preventative benefit for lung cancer or colon cancer. One of the eight completed studies was the first ever Phase 0 chemoprevention study designed to determine the type of capsule or tablet that will deliver the best dose of active ingredients to humans.

Currently, there is one study open and actively recruiting participants at Thomas Jefferson University in Philadeophia. This study, MAY2012-00-01 is attempting to show whether or not a drug called linaclotide can reach and affect the colon. If it does, this may lead to another colon cancer prevention study in the future. The other is a phase II study involving a vaccine that may prevent the growth of polyps and adenomas, pre-cancerous growths in the colon and rectum.

There three studies are in development. One is a study of a vaccine for the prevention of recurrence of colon adenomas and colorectal cancer. The other two studies in development involve prevention of hepatocellular carcinoma (HCC). One involves a DNa vaccine and the other involves the study agent, erlotinib.

Are You Interested in Participating?

We are seeking healthy adults who might be at risk for the cancers mentioned above. If you would like to participate in one of these studies, please contact one of CPN's member organizations or CPN's Operations Office.