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NCT00258349 · ClinicalTrials.gov registry record · Phase 1
Vorinostat and Trastuzumab in Treating Patients With Metastatic or Locally Recurrent Breast Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT00258349: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00258349 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00258349, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This phase I/II trial is studying the side effects and best dose of vorinostat when given together with trastuzumab and to see how well they work in treating patients with metastatic breast canceror breast cancer that has recurred in the chest wall. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Vorinostat and trastuzumab also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving vorinostat together with trastuzumab may be a better way to block tumor growth.
Primary Outcome
Tumor response is assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Response included complete response (CR) and partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.
Interventions
- DRUG vorinostat
- DRUG trastuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2006-08 |
| Est. Completion | 2010-09 |
| Phase | Phase 1 |
What the finished NCT00258349 record still lists
NCT00258349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which vorinostat is the first listed.
NCT00258349 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00258349 about?
NCT00258349 is a clinical study titled "Vorinostat and Trastuzumab in Treating Patients With Metastatic or Locally Recurrent Breast Cancer". This phase I/II trial is studying the side effects and best dose of vorinostat when given together with trastuzumab and to see how well they work in treating patients with metastatic breast canceror breast cancer that has recurred in the chest wall. Vorinostat may stop the growth of tumor cells by b...
What is the current status of trial NCT00258349?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2006-08. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00258349?
The interventions under investigation include: vorinostat (DRUG), trastuzumab (DRUG).
Who is sponsoring clinical trial NCT00258349?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00258349's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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