NCT01353664

A Rollover Study for Patients Who Participated in Other Romidepsin Protocols

An Open Label, Single-Arm Rollover Study for Subjects Who Participated In Other Romidepsin Protocols

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants must have previously participated in a Romidepsin study sponsored by Gloucester Pharmaceuticals or Celgene Corporation.

Conditions

• Lymphoma
• Cancer

Interventions

Type	Name	Description
DRUG	Romidepsin	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.

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-09-05
• Completion: 2012-09-05
• First posted: 2011-05-16
• Last updated: 2019-11-25
• Results posted: 2013-12-19

Locations

3 sites across 2 countries: United States, United Kingdom