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NCT00499122 · ClinicalTrials.gov registry record · Phase 2

NOV-002, Doxorubicin, Cyclophosphamide, and Docetaxel in Women With Newly Diagnosed Stage II or IIIC Breast Cancer

A Phase 2 study, sponsored by University of Miami.

Completed
Registry status
Phase 2
Development phase
41
Enrollment target

NCT00499122 is a Phase 2 study that has completed, run by University of Miami. The registered enrollment target is 41 participants.

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The verdict

NCT00499122, a Phase 2 study, has completed, sponsored by University of Miami.

COMPLETED
Registry status
Phase 2
Development phase
41 participants
Enrollment target

Study Summary

RATIONALE: Oxidized glutathione (NOV-002) may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving NOV-002 together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving oxidized glutathione (NOV-002) together with doxorubicin and cyclophosphamide followed by docetaxel works in treating women with newly diagnosed stage II or stage III breast cancer.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Docetaxel
  • DRUG Doxorubicin
  • DRUG NOV 002

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2007-06-04
Est. Completion 2011-04
Phase Phase 2

Sponsor

University of Miami

721 total trials

What the Registry Record Tells You About NCT00499122

The ClinicalTrials.gov registry entry for NCT00499122 describes a study currently listed as completed, categorized as Phase 2. 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 University of Miami, which has 721 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.

NCT00499122 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00499122 about?

NCT00499122 is a clinical study titled "NOV-002, Doxorubicin, Cyclophosphamide, and Docetaxel in Women With Newly Diagnosed Stage II or IIIC Breast Cancer". RATIONALE: Oxidized glutathione (NOV-002) may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by...

What is the current status of trial NCT00499122?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2007-06-04. Estimated completion is 2011-04.

What interventions are being tested in trial NCT00499122?

The interventions under investigation include: Cyclophosphamide (DRUG), Docetaxel (DRUG), Doxorubicin (DRUG), NOV 002 (DRUG).

Who is sponsoring clinical trial NCT00499122?

This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.

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

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.