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NCT01084057 · ClinicalTrials.gov registry record · Phase 1
Ixabepilone and Vorinostat in Treating Patients With Metastatic Breast Cancer
A Phase 1 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT01084057: Completed Phase 1 study, sponsored by City of Hope Medical Center.
NCT01084057 is a Phase 1 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01084057, a Phase 1 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 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 or by stopping them from spreading. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ixabepilone together with vorinostat may kill more tumor cells. PURPOSE: This randomized phase I trial is studying the side effects, best way to give, and best dose of vorinostat when given together with ixabepilone in treating patients with breast cancer that has spread to another place in the body.
Primary Outcome
Graded according to the National Cancer Institute (NCI) CTCAE version 4.0. DLT is defined for each dose level and will include both drugs ixabepilone and vorinostat.
Interventions
- OTHER laboratory biomarker analysis
- DRUG vorinostat
- OTHER pharmacological study
- DRUG ixabepilone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2010-05-17 |
| Est. Completion | 2019-09-27 |
| Phase | Phase 1 |
What the finished NCT01084057 record still lists
NCT01084057 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01084057 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01084057 about?
NCT01084057 is a clinical study titled "Ixabepilone and Vorinostat 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 or by stopping them from spreading. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed...
What is the current status of trial NCT01084057?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2010-05-17. Estimated completion is 2019-09-27.
What interventions are being tested in trial NCT01084057?
The interventions under investigation include: laboratory biomarker analysis (OTHER), vorinostat (DRUG), pharmacological study (OTHER), ixabepilone (DRUG).
Who is sponsoring clinical trial NCT01084057?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01084057's enrollment target sits among peer trials
56 902nd of 2000 higher than 1,083 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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