Safety and tolerability of ONO-4059 in patients with NHL & CLL

• Research type

  Research Study

• Full title

  An open-label, multi-centre, non-randomised phase I dose-escalation study to investigate the safety and tolerability of ONO-4059 given as monotherapy in patients with relapsed/refractory Non-Hodgkin's lymphoma (NHL) and relapsed/refractory chronic lymphocytic leukaemia (CLL).

• IRAS ID

  106365

• Contact name

  Martin Dyer

• Sponsor organisation

  Ono Pharmaceutical Co Ltd

• Eudract number

  2011-005033-39

• ISRCTN Number

  N/A

• Research summary

  This is a study to test the experimental drug ONO-4059, a new anticancer agent, in patients with types of advanced blood cancer. Laboratory studies have shown that ONO-4059 helps to reduce the growth of some cancer cells. The study is designed to investigate the safety and tolerability of ONO-4059 in humans, and to identify a dose that can be used in the future. As ONO-4059 has not been given to humans before, the study will start with one patient taking ONO-4059 once a day for 15 days. This patient will be closely monitored and assessed. If the study doctors and study team are happy that the patient is not experiencing unacceptable side effects, the patient will continue and further patients in this dose group can start on the study. The dose for subsequent groups will increase until a maximum dose has been identified. All patients will be closely monitored and assessed throughout the study. We are also investigating how the body handles ONO-4059 (i.e. how quickly the body absorbs and removes the drug) and how genes (building blocks of cells) affect the way the body responds to or handles the drug. Patients will be recruited from up to 8 clinical centres in Europe. If patients consent to enter this study they will attend hospital visits throughout the study - visits will be most frequent during the first 28 days of treatment. At visits, patients will undergo assessments to check on their health and see how ONO-4059 is working. Patients can receive ONO-4059 treatment for up to 12 months if they are responding to the treatment and are not experiencing unacceptable side effects.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  12/EM/0204

• Date of REC Opinion

  26 Jul 2012

• REC opinion

  Further Information Favourable Opinion