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NCT00244933 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine Hydrochloride and Genistein in Treating Women With Stage IV Breast Cancer
A Phase 2 study, sponsored by Barbara Ann Karmanos Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT00244933: Completed Phase 2 study, sponsored by Barbara Ann Karmanos Cancer Institute.
NCT00244933 is a Phase 2 study that has completed, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00244933, a Phase 2 study, has completed, sponsored by Barbara Ann Karmanos Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and genistein, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine hydrochloride together with genistein may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine hydrochloride together with genistein works in treating women with stage IV breast cancer.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Interventions
- PROCEDURE Tumor biopsy
- DRUG gemcitabine
- DIETARY_SUPPLEMENT genistein
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2004-02 |
| Est. Completion | 2009-10 |
| Phase | Phase 2 |
What the finished NCT00244933 record still lists
NCT00244933 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 3 interventions - of which Tumor biopsy is the first listed.
NCT00244933 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00244933 about?
NCT00244933 is a clinical study titled "Gemcitabine Hydrochloride and Genistein in Treating Women With Stage IV Breast Cancer". RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and genistein, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine hydrochloride together with genistein may kill more tumor cells. PURPOS...
What is the current status of trial NCT00244933?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2004-02. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00244933?
The interventions under investigation include: Tumor biopsy (PROCEDURE), gemcitabine (DRUG), genistein (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00244933?
This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00244933's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 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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