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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-05-22

Study results available
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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.

Conditions

  • Colorectal Neoplasms

Interventions

DRUG

KD018

Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.

DRUG

Irinotecan

Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².

DRUG

Placebo

Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.

Sponsors & Collaborators

  • Kadmon Corporation, LLC

    collaborator INDUSTRY

  • Edward Chu, MD

    lead OTHER

Principal Investigators

  • Edward Chu, MD · Hillman Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2016-06-30
Completion
2018-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00730158 on ClinicalTrials.gov