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NCT00645333 · ClinicalTrials.gov registry record · Phase 1

Phase I/II Study of MK-0752 Followed by Docetaxel in Advanced or Metastatic Breast Cancer

A Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT00645333 is a Phase 1 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 30 participants.

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The verdict

NCT00645333, a Phase 1 study, has completed, sponsored by University of Michigan Rogel Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

New and better therapies for locally advanced and metastatic breast cancer are needed because, even if standard treatment is successful in shrinking the cancer, there is still a high chance that the cancer will recur. Recent research suggests that breast tumors have a small number of cells in them that are "breast cancer stem cells", which are very resistant to standard treatment. It is thought that the reason that many patients cannot be cured of their breast cancers is that the stem cells are unable to be killed and remain in the body after standard treatment. Laboratory research has shown that a new drug, MK-0752, can target stem cells and prevent tumor recurrences when the drug is combined with docetaxel, a chemotherapy drug commonly used to treat breast cancer. We know that MK-0752 is safe when given by itself to people. We do not know if treatment with MK-0752 and docetaxel combined is safe or if it will kill "breast cancer stem cells" in people with breast cancer. This clinical trial is being done to determine the safety of several doses of MK-0752 in combination with docetaxel. Preliminary data about the effectiveness of MK-0752 in combination with docetaxel will be collected. Also, tumor biopsy samples will be taken from some patients who have tumors that can be easily biopsied. The samples will be used to perform research tests to help determine if the "breast cancer stem cells" are being killed by the drug combination.

Interventions

  • DRUG MK-0752, Docetaxel, Pegfilgrastim

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2008-03
Est. Completion 2012-10
Phase Phase 1

What the Registry Record Tells You About NCT00645333

The ClinicalTrials.gov registry entry for NCT00645333 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which MK-0752, Docetaxel, Pegfilgrastim is the first listed.

NCT00645333 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00645333 about?

NCT00645333 is a clinical study titled "Phase I/II Study of MK-0752 Followed by Docetaxel in Advanced or Metastatic Breast Cancer". New and better therapies for locally advanced and metastatic breast cancer are needed because, even if standard treatment is successful in shrinking the cancer, there is still a high chance that the cancer will recur. Recent research suggests that breast tumors have a small number of cells in them t...

What is the current status of trial NCT00645333?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2008-03. Estimated completion is 2012-10.

What interventions are being tested in trial NCT00645333?

The interventions under investigation include: MK-0752, Docetaxel, Pegfilgrastim (DRUG).

Who is sponsoring clinical trial NCT00645333?

This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 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.