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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, Single-Arm Rollover Study for Subjects Who Participated In Other Romidepsin Protocols|
- Number of Participants With Treatment Emergent Adverse Events (TEAE) [ Time Frame: Up to 231 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2011|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
This study is an open-label, single-arm study. The study is divided into the Screening Period, Treatment Period, and Follow-up Period.
The participants will generally continue at the same dose, infusion time and frequency used for the last dose of romidepsin given in the preceding romidepsin study. If the participant entered this rollover study in the middle of a cycle, then the cycle number and cycle day will be carried over from the preceding romidepsin study.
Other Name: Istodax®, ROMI
Participants must have previously participated in a Romidepsin study sponsored by Gloucester Pharmaceuticals or Celgene Corporation.
|United States, Florida|
|Florida Cancer Specialists|
|Sarasota, Florida, United States, 34232|
|United States, Tennessee|
|Sarah Cannon Research Institute|
|Nashville, Tennessee, United States, 37203|
|Sarah Cannon Research UK|
|London, United Kingdom, W1G6AD|
|Study Director:||Ken Takeshita, MD||Celgene Corporation|