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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | KD018 | Traditional medicine (herbal / TCM) | 1800 mg | Oral |
| Background | Irinotecan | Small molecule | 215 mg/m2 | Intravenous |