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NCT00765765 · ClinicalTrials.gov registry record · Phase 1
Ixabepilone and Hydroxychloroquine in Treating Patients With Metastatic Breast Cancer
A Phase 1 study, sponsored by University of Medicine and Dentistry of New Jersey.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT00765765: Clinical Trial Phase 1 study, sponsored by University of Medicine and Dentistry of New Jersey.
NCT00765765 is a Phase 1 study that was terminated before completion, run by University of Medicine and Dentistry of New Jersey. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00765765, a Phase 1 study, was terminated before completion, sponsored by University of Medicine and Dentistry of New Jersey.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hydroxychloroquine may help ixabepilone work better by making tumor cells more sensitive to the drug. PURPOSE: This phase I/II trial is studying the side effects and best dose of ixabepilone given together with hydroxychloroquine and to see how well they work in treating patients with metastatic breast cancer.
Primary Outcome
Overall Complete Response and Partial Response will be considered tumor response. Ixabepilone as a single agent (40 mg/m2 as an intravenous infusion every 3 weeks) was evaluated in a previous (Phase II) study in women with metastatic breast cancer and that the objective tumor response rate was 11.5%. In another(Phase III) study, Ixabepilone in combination with capecitabine resulted in an objective tumor response rate of 35%, compared to that of capecitabine alone (14%). Therefore, in the Phase I
Interventions
- DRUG ixabepilone
- DRUG hydroxychloroquine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2009-02 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
Why NCT00765765 stopped before completion
NCT00765765 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which ixabepilone is the first listed.
NCT00765765 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00765765 about?
NCT00765765 is a clinical study titled "Ixabepilone and Hydroxychloroquine in Treating Patients With Metastatic Breast Cancer". RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hydroxychloroquine may help ixabepilone work better by making tumor cells more sensitive to the drug. PURPOSE: This ph...
What is the current status of trial NCT00765765?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2009-02. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00765765?
The interventions under investigation include: ixabepilone (DRUG), hydroxychloroquine (DRUG).
Who is sponsoring clinical trial NCT00765765?
This trial is sponsored by University of Medicine and Dentistry of New Jersey, which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00765765's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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