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NCT00546364 · ClinicalTrials.gov registry record · Phase 2
Randomized Study Evaluating Ixabepilone Plus Capecitabine or Docetaxel Plus Capecitabine in Metastatic Breast Cancer
A Phase 2 study, sponsored by R-Pharm.
- Terminated
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
NCT00546364: Clinical Trial Phase 2 study, sponsored by R-Pharm.
NCT00546364 is a Phase 2 study that was terminated before completion, run by R-Pharm. The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00546364, a Phase 2 study, was terminated before completion, sponsored by R-Pharm.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effect of ixabepilone plus capecitabine or docetaxel plus capecitabine on shrinking or slowing the growth of metastatic breast cancer in women. The safety of this combination therapy will also be evaluated.
Primary Outcome
RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator.
Interventions
- DRUG Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
- DRUG Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
- DRUG Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2008-02 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
Why NCT00546364 stopped before completion
NCT00546364 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 3 interventions - of which Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 is the first listed.
NCT00546364 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00546364 about?
NCT00546364 is a clinical study titled "Randomized Study Evaluating Ixabepilone Plus Capecitabine or Docetaxel Plus Capecitabine in Metastatic Breast Cancer". The purpose of this study is to assess the effect of ixabepilone plus capecitabine or docetaxel plus capecitabine on shrinking or slowing the growth of metastatic breast cancer in women. The safety of this combination therapy will also be evaluated.
What is the current status of trial NCT00546364?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2008-02. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00546364?
The interventions under investigation include: Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 (DRUG), Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 (DRUG), Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 (DRUG).
Who is sponsoring clinical trial NCT00546364?
This trial is sponsored by R-Pharm, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00546364's enrollment target sits among peer trials
62 1016th of 2000 higher than 975 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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