CAMN107EIC01 ENEST 1st

• Research type

  Research Study

• Full title

  A phase IIIb, multicentre, open-label study of nilotinib in adult patients with newly diagnosed Philadelphia chromosome and/or BCR-ABL positive CML in chronic phase

• IRAS ID

  46927

• Contact name

  David Marin Costa

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2009-017775-19

• ISRCTN Number

  N/A

• Research summary

  This is a multi-centre, single-arm study of nilotinib 300mg twice daily as first treatment of patients with newly diagnosed Philadelphia chromosome (ph) and /or BCR-ABL positive Chronic Myeloid Leukaemia. Thirty patients in the UK will be enrolled from 15 sites with established experience in cancer clinical trials. Overall 806 patients will be enrolled into the study in Europe and will receive nilotinib 300mg twice daily for 24 months. Following completion of 18 months of study treatment patients will continue to receive drug and be followed-up for a further 6 months to determine early progression.

• REC name

  North East - York Research Ethics Committee

• REC reference

  10/H0903/15

• Date of REC Opinion

  3 Jun 2010

• REC opinion

  Further Information Favourable Opinion