ROMI-ADVM-004 dated 7 January 2011

• Research type

  Research Study

• Full title

  AN OPEN-LABEL, SINGLE-ARM ROLLOVER STUDY FOR SUBJECTS WHO PARTICIPATED IN OTHER ROMIDEPSIN PROTOCOLS

• IRAS ID

  71853

• Contact name

  Hendrik-Tobias Arkenau

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2010-023040-32

• ISRCTN Number

  Not Known

• Research summary

  The purpose of this study is to allow access to romidepsin for subjects who have received romidepsin previously in either the ROMI-ADVM-001 study or the or ROMI-ADVM-002 study and the investigator feels may benefit from continuing treatment with romidepsin.Only Adult patients with advanced cancers who have received romidepsin in the ROMI-ADVM-001 study or the or ROMI-ADVM-002 study will be eligible to participate. This study will also evaluate the safety of intravenous infusion of romidepsin, by performing blood tests, cardiac & vital sign monitoring.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  11/LO/0265

• Date of REC Opinion

  1 Jun 2011

• REC opinion

  Further Information Favourable Opinion