drugset / Trial / NCT00730158

A Phase II Multicenter, Randomized, Placebo Controlled, Double Blinded Clinical Study of KD018 as a Modulator of Irinotecan Chemotherapy in Patients With Metastatic Colorectal Cancer

NCT00730158 ↗

Phase 2 Completed 33 enrolled Edward Chu, MD Kadmon Corporation, LLC · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The proposed plan will investigate the mechanism and efficacy of Chinese herbal medicine as an adjunct to chemotherapy in treatment of patients with metastatic colorectal cancer. Our rationale for the therapeutic use of KD018 is its potential activity in reducing chemotherapy-induced toxicity, especially diarrhea.

Timeline

Start
2008-12
Primary completion
2016-06
Completion
2018-06

Drugs

EvaluationDrugModalityDoseRoute
Subject KD018 Traditional medicine (herbal / TCM) 1800 mg Oral
Background Irinotecan Small molecule 215 mg/m2 Intravenous

Indications