drugset / Trial / NCT01985763

Genistein in Treatment of Metastatic Colorectal Cancer

NCT01985763

Phase 1/2 Completed 13 enrolled Sofya Pintova dsm-firmenich Switzerland AG · collab
NaSingle-groupOpen-labelTreatment

Summary

Colorectal neoplasms are the third most common malignancies in the United States. Patients with metastatic (stage IV) colorectal cancer have a median life expectancy of 2 years. The response rates to chemotherapy range from 35-40%. Epidemiologic evidence suggests that soy compounds may reduce the incidence of colorectal cancers. Laboratory analyses demonstrate that genistein, a soy-derived compound, may inhibit Wnt signaling, a pathway activated in majority of colorectal cancers. Laboratory observations also demonstrate that genistein may augment growth inhibition when combined with chemotherapeutic agents of 5-Fluorouracil and platinum compounds. Based on pre-clinical data the investigators hypothesize that combining genistein with the standard of care chemotherapeutic regimens will reduce chemotherapy resistance and improve response rates in patients. The aim of the study is to add genistein to the regimens of FOLFOX or FOLFOX-Avastin in patients with newly diagnosed stage IV colon or rectal neoplasms.

Timeline

Start
2013-11
Primary completion
2017-01-19
Completion
2018-10-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Genistein Other / unclassified 60 mg Oral