BAY 87-2243 in subjects with advanced malignancies

• Research type

  Research Study

• Full title

  An open-label, Phase I, dose-escalation study to characterize the safety, tolerability, pharmacokinetics, and maximum tolerated dose of BAY 87-2243 given once daily in subjects with advanced malignancies

• IRAS ID

  72267

• Contact name

  Udai Banerji

• Sponsor organisation

  Bayer HealthCare AG

• Eudract number

  2010-023403-10

• ISRCTN Number

  not issued

• Research summary

  As cancer grows in the body, it needs nutrients, oxygen and blood supply. As it grows, parts of the tumour get less oxygen and release a substance called hypoxia inducible factor (HIF) which stimulates the body to increase the number of blood vessels to the tumour which allows it to grow. BAY 87-2243 is a drug that was developed to oppose the action of (HIF) thus reducing the blood supply to tumours. It is envisaged that this will be helpful in the treatment of cancer.This is a first in human phase I trial of the drug BAY 87-2243 which is being researched for its use in the treatment of cancer. This trial will be conducted in patients with advanced cancer in whom there are no further standard treatments. The primary purpose of this study is to define the maximum tolerated dose. The trial will also involve taking blood before and after treatment for the purposes of pharmacokinetic studies (study of the amount of drug in the body and how it is removed from the body) and pharmacodynamics (study of how the drug effects the target proteins)The study will be conducted in 3-4 centres (United Kingdom, Germany and Norway). Three patients will be enrolled at each dose. If significant side effects are seen in 2 out of 3 patients, then no further patients will be dosed with the drug. If one out of 3 patients have significant side effects a further 3 patients will be enrolled. If less than 2 out of 6 patients have significant side effects, further patients will be enrolled, and the dose increased cautiously. If the dose described is safe, up to 25 further patients may be treated to assess if the drug can shrink tumours.Recruitment anticipated 2012

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/0090

• Date of REC Opinion

  9 May 2011

• REC opinion

  Further Information Favourable Opinion