Phase I/Ib Study of BEZ235 In Patients with Advanced Solid Tumours

• Research type

  Research Study

• Full title

  A phase I/Ib, multicentre, open label study of BEZ235, administered orally on a continuous daily dosing schedule in adult patients with advanced solid malignancies including patients with advanced breast cancer

• IRAS ID

  32985

• Contact name

  Malcolm Ranson

• Sponsor organisation

  Novartis Pharma Services

• Eudract number

  2006-004353-23

• ISRCTN Number

  N/A

• Research summary

  The novel agent BEZ235 is being developed by Novartis Pharmaceuticals (the Study sponsor) and acts by blocking a protein called PI3K that has an important role in the development and growth of several different cancers. The drug BEZ235 has previously been shown to prevent or reduce the growth of tumours in laboratory experiments and animals but this is the first clinical research study to be carried out in humans. Therefore there is no guarantee that participants will draw benefit from BEZ235.BEZ235 will be administered orally as a hard gelatin capsule to patients with advanced solid tumours, in whom all available lines of standard therapy have been exhausted or no standard anticancer therapy exists.The study is a Phase I/Ib trial and includes several parts: a single agent dose escalation phase with BEZ235 alone, a single agent dose expansion phase and a dose escalation phase of BEZ235 in combination with trastuzumab.The aims of this study are: to find the highest dose of the study drug BEZ235 that can be given safely to humans, to study how the body handles BEZ235, and to see if BEZ235 causes any changes to the tumour. Combination Dose Escalation Phase Laboratory tests have shown that BEZ235 can restore the sensitivity of cancer cells when they have become resistant to the drug trastuzumab. In order to study this further this study includes a group of patients where BEZ235 is given in combination with trastuzumab. Patients must provide written consent & meet specific trial entry criteria, BEZ235 will be given either as a single agent, or in combination with trastuzumab, over a 28 day cycle. Patients will be monitored closely throughout the study to assess their health and response to BEZ235. Study treatment with BEZ235 can continue until evidence of progressive disease, unacceptable side effects, or withdrawal of patient's consent.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  09/H1008/133

• Date of REC Opinion

  3 Dec 2009

• REC opinion

  Further Information Favourable Opinion