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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: Completed Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
NCT00645333 is a Phase 1 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The number of DLTs experienced by participants within the first 21 days. DLTs were defined as toxicities possibly, probably, or definitely related to the study drug observed during the first 2 cycles (first 42 days) as follows: 1. Non-hematologic toxicity Grade ≥3 by the NCI CTCAE version 3.0. 2. ANC\<1000 for more than 7 days despite use of pegfilgrastim. 3. Platelet count \<25,000 for more than 7 days, or associated with bleeding, or less than 10,000 at any time.
Interventions
- DRUG MK-0752, Docetaxel, Pegfilgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2008-03 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
What the finished NCT00645333 record still lists
NCT00645333 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which MK-0752, Docetaxel, Pegfilgrastim is the first listed.
NCT00645333 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00645333's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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