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COMPLETED Phase 2

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 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DRUG Placebo
  • DRUG Irinotecan
  • DRUG KD018

Study Locations (2)

Connecticut

  • Yale University Comprehensive Cancer Center — New Haven

Pennsylvania

  • Hillman CancerCenters — Pittsburgh

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2008-12
Est. Completion 2018-06
Phase Phase 2

Sponsor

Edward Chu, MD

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00730158

The ClinicalTrials.gov registry entry for NCT00730158 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edward Chu, MD, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Colorectal Neoplasms appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00730158 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Connecticut, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00730158 about?

NCT00730158 is a clinical study titled "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". 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, espec...

What is the current status of trial NCT00730158?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2008-12. Estimated completion is 2018-06.

What conditions does trial NCT00730158 study?

This clinical trial studies the following conditions: Colorectal Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00730158?

The interventions under investigation include: Placebo (DRUG), Irinotecan (DRUG), KD018 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00730158?

This trial is sponsored by Edward Chu, MD, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00730158 being conducted?

This trial has 2 study locations across Connecticut, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial