ROMI-ADVM-001 amendment 2 dated 07 January 2011 re submission

• Research type

  Research Study

• Full title

  A PHASE I OPEN-LABEL, 2-PERIOD STUDY TO EVALUATE THE INFLUENCE OF MULTIPLE ORAL DOSES OF KETOCONAZOLE ON THE SINGLE DOSE PHARMACOKINETICS OF ROMIDEPSIN IN SUBJECTS WITH ADVANCED CANCER

• IRAS ID

  72875

• Contact name

  Hendrik-Tobias Arkenau

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2010-022144-20

• ISRCTN Number

  Not Known

• Research summary

  This study evaluates the effect and safety of multiple doses of ketoconazole on the pharmacokinetics or PK (how the drug is broken down, used and eliminated from the body) of romidepsin after a single intravenous (IV) infusion. The purpose of this study is to investigate whether there is a possibility that the way Romidepsin acts in the body can be affected by the use of another medication ?? in this case Ketoconazole ?? resulting in a drug interaction. Drug interactions may cause the drug to be more or less effective, or cause effects on the body that are not expected. Adult patients with advanced cancers who have failed standard treatments will be eligible to participate

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  11/LO/0264

• Date of REC Opinion

  1 Jun 2011

• REC opinion

  Further Information Favourable Opinion