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NCT01353664 · ClinicalTrials.gov registry record · Phase 2
A Rollover Study for Patients Who Participated in Other Romidepsin Protocols
A Phase 2 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT01353664: Completed Phase 2 study, sponsored by Celgene.
NCT01353664 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01353664, a Phase 2 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
This study is intended to provide access to Romidepsin for participants who received Romidepsin in other trials sponsored by Gloucester Pharmaceuticals or Celgene Corporation and for participants whom the investigator feels may benefit from continuing treatment with Romidepsin.
Primary Outcome
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4: On the following is the scale: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death. Serious AEs (SAEs) are those that resu
Interventions
- DRUG Romidepsin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2011-05-01 |
| Est. Completion | 2012-09-05 |
| Phase | Phase 2 |
What the finished NCT01353664 record still lists
NCT01353664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Romidepsin is the first listed.
NCT01353664 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01353664 about?
NCT01353664 is a clinical study titled "A Rollover Study for Patients Who Participated in Other Romidepsin Protocols". This study is intended to provide access to Romidepsin for participants who received Romidepsin in other trials sponsored by Gloucester Pharmaceuticals or Celgene Corporation and for participants whom the investigator feels may benefit from continuing treatment with Romidepsin.
What is the current status of trial NCT01353664?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2011-05-01. Estimated completion is 2012-09-05.
What interventions are being tested in trial NCT01353664?
The interventions under investigation include: Romidepsin (DRUG).
Who is sponsoring clinical trial NCT01353664?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01353664's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 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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