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NCT01938833 · ClinicalTrials.gov registry record · Phase 1
Romidepsin and Abraxane in Treating Patients With Metastatic Inflammatory Breast Cancer
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01938833: Clinical Trial Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT01938833 is a Phase 1 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01938833, a Phase 1 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of romidepsin when given together with paclitaxel albumin-stabilized nanoparticle formulation and to see how well they work in treating patients with metastatic inflammatory breast cancer. Romidepsin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving romidepsin and paclitaxel albumin-stabilized nanoparticle formulation may be an effective treatment for inflammatory breast cancer.
Primary Outcome
Determined according to incidence of dose-limiting toxicity, graded using the National Cancer Institute (NCI) CTCAE version 4.0
Interventions
- DRUG Abraxane
- DRUG Romidepsin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2014-04 |
| Est. Completion | 2016-12-08 |
| Phase | Phase 1 |
Why NCT01938833 stopped before completion
NCT01938833 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Abraxane is the first listed.
NCT01938833 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01938833 about?
NCT01938833 is a clinical study titled "Romidepsin and Abraxane in Treating Patients With Metastatic Inflammatory Breast Cancer". This phase I/II trial studies the side effects and best dose of romidepsin when given together with paclitaxel albumin-stabilized nanoparticle formulation and to see how well they work in treating patients with metastatic inflammatory breast cancer. Romidepsin may stop the growth of tumor cells by b...
What is the current status of trial NCT01938833?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2014-04. Estimated completion is 2016-12-08.
What interventions are being tested in trial NCT01938833?
The interventions under investigation include: Abraxane (DRUG), Romidepsin (DRUG).
Who is sponsoring clinical trial NCT01938833?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01938833's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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