CPP Clinical Trials

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.

FAP-310 Pivotal Phase 3 Trial  (Familial Adenomatous Polyposis)

Cancer Prevention Pharmaceuticals has evaluated a new drug combination CPP-1X/sul for patients with FAP (familial adenomatous polyposis). This trial was to determine if a combination drug treatment can work better than each drug alone in preventing the disease from getting worse. It also looked 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.

Combination Therapy for FAP
The two drugs used in this study were 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. 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).

Status: Completed
All patients have completed treatment, results have been presented and regulatory pathways are being pursued. For more detailed information on the study go to ClinicalTrials.gov.

PACES Phase 3 Study  (Colon Cancer Risk Reduction)

A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients With Stage 0-III Colon or Rectal Cancer, Phase III – Preventing Adenomas of the Colon With Eflornithine and Sulindac (PACES).

PACES is funded by National Cancer Institute in collaboration with SWOG

Status:  Recruiting 
For information about participating in the trial contact CPP:  clinical@canprevent.com

COG Phase 2 Study  (Neuroblastoma)

A COG Groupwide Phase 2 randomized study of Irinotecan Hydrochloride, Temozolomide, Dinutuximab with or without Eflornithine (DFMO) in children with Relapsed, Refractory or Progressive Neuroblastoma.  Open to Institutions within the United States and Canada.
For more detailed information on the study go to ClinicalTrials.gov.

Status:  Recruiting
For information about participating in the trial contact CPP:  clinical@canprevent.com