drugset / Trial / NCT03300570

Dolcanatide in Preventing Colorectal Cancer in Healthy Volunteers

NCT03300570 ↗

Phase 1 Completed 27 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupDouble-blindPrevention

Summary

This phase I trial studies how well dolcanatide works in preventing colorectal cancer in healthy participants. Dolcanatide is similar to a natural hormone released into the intestine. It is thought that people who have low levels of the hormone are more likely to get colon cancer. It may be possible to prevent colon cancer by giving a drug that is similar to the hormone, such as dolcanatide.

Timeline

Start
2018-07-27
Primary completion
2019-01-02
Completion
2021-05-17

Outcome

Missed primary endpoint

registry analysis (superiority test); Arm B (Dolcanatide) vs Arm A (Placebo); p = 0.15; Wilcoxon (Mann-Whitney) NCT03300570 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dolcanatide Protein / enzyme biologic 27 mg Oral

Indications