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NCT00522665 · ClinicalTrials.gov registry record · Phase 1

Phase I/Randomized Phase II Study of Second Line Therapy With Irinotecan + Cetuximab +/- RAD001 for Colorectal Cancer

A Phase 1 study, sponsored by Hoosier Cancer Research Network.

Completed
Registry status
Phase 1
Development phase
41
Enrollment target

NCT00522665 is a Phase 1 study that has completed, run by Hoosier Cancer Research Network. The registered enrollment target is 41 participants.

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The verdict

NCT00522665, a Phase 1 study, has completed, sponsored by Hoosier Cancer Research Network.

COMPLETED
Registry status
Phase 1
Development phase
41 participants
Enrollment target

Study Summary

The addition of RAD001, an mTOR inhibitor, to irinotecan and anti-EGFR antibody cetuximab may increase efficacy for patients with metastatic colorectal cancer who progressed on prior chemotherapy. This approach is biologically directed to overall target the cancer cell at multiple levels, and potentially preventing chemotherapy and EGFR-therapy resistance.

Interventions

  • BIOLOGICAL Cetuximab
  • DRUG Irinotecan
  • BIOLOGICAL RAD001

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2007-08
Est. Completion 2015-02
Phase Phase 1

Sponsor

Hoosier Cancer Research Network

26 total trials

What the Registry Record Tells You About NCT00522665

The ClinicalTrials.gov registry entry for NCT00522665 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoosier Cancer Research Network, which has 26 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Cetuximab is the first listed.

NCT00522665 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00522665 about?

NCT00522665 is a clinical study titled "Phase I/Randomized Phase II Study of Second Line Therapy With Irinotecan + Cetuximab +/- RAD001 for Colorectal Cancer". The addition of RAD001, an mTOR inhibitor, to irinotecan and anti-EGFR antibody cetuximab may increase efficacy for patients with metastatic colorectal cancer who progressed on prior chemotherapy. This approach is biologically directed to overall target the cancer cell at multiple levels, and potent...

What is the current status of trial NCT00522665?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2007-08. Estimated completion is 2015-02.

What interventions are being tested in trial NCT00522665?

The interventions under investigation include: Cetuximab (BIOLOGICAL), Irinotecan (DRUG), RAD001 (BIOLOGICAL).

Who is sponsoring clinical trial NCT00522665?

This trial is sponsored by Hoosier Cancer Research Network, which has 26 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.