1280.2 BI 836845 IGF Study

• Research type

  Research Study

• Full title

  A Phase I dose escalation trial of BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours with repeated administrations in patients showing clinical benefit

• IRAS ID

  69106

• Contact name

  Johann de Bono

• Eudract number

  2010-021714-29

• ISRCTN Number

  not issued

• Research summary

  This study is a phase I, open-label, dose escalation trial to determine the maximum tolerated dose (MTD) of a new drug BI 836845 which blocks the IGF pathway believed to be involved in cancer growth. BI 836845 will be administered for the very first time into cancer patients.The study will also look at the overall safety of the drug, and examine the drug levels in the body at specific timepoints during the trial (pharmacokinetic profile); the effect the drug may have on tumours will also be examined (pharmacodynamics). BI 836845 will be administered intravenously over one hour once every three weeks in patients with any type of advanced solid tumour. In addition, this study will also plan to have an expansion cohort so as to include patients with tumour types more likely to benefit from BI 836845. This part of the study will aim to collect more detailed pharmacokinetic, pharmacodynamic and safety data, as well as to detect any early efficacy signals in tumours.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/0063

• Date of REC Opinion

  7 Apr 2011

• REC opinion

  Further Information Favourable Opinion