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NCT00323063 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine +/- Imatinib Mesylate, Patients w/Previously Treated Metastatic Breast Cancer
A Phase 2 study, sponsored by Rutgers, The State University of New Jersey.
- Terminated
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT00323063: Clinical Trial Phase 2 study, sponsored by Rutgers, The State University of New Jersey.
NCT00323063 is a Phase 2 study that was terminated before completion, run by Rutgers, The State University of New Jersey. The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00323063, a Phase 2 study, was terminated before completion, sponsored by Rutgers, The State University of New Jersey.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells. PURPOSE: This randomized phase II trial is studying gemcitabine and imatinib mesylate to see how well they work compared to gemcitabine alone in treating patients with previously treated locally advanced or metastatic breast cancer.
Primary Outcome
Sample size of 40 patients per group was needed to detect an 8 month increase in time to progression with the combination (80% power, alpha =.05, 2-sided).
Interventions
- DRUG imatinib mesylate
- DRUG gemcitabine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2006-05-01 |
| Est. Completion | 2016-06-20 |
| Phase | Phase 2 |
Why NCT00323063 stopped before completion
NCT00323063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which imatinib mesylate is the first listed.
NCT00323063 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00323063 about?
NCT00323063 is a clinical study titled "Gemcitabine +/- Imatinib Mesylate, Patients w/Previously Treated Metastatic Breast Cancer". RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gem...
What is the current status of trial NCT00323063?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2006-05-01. Estimated completion is 2016-06-20.
What interventions are being tested in trial NCT00323063?
The interventions under investigation include: imatinib mesylate (DRUG), gemcitabine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00323063?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00323063's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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