BKM120 in patients with metastatic NSCLC with activated PI3K pathway

• Research type

  Research Study

• Full title

  An open label two-stage study of orally administered BKM120 in patients with metastatic non-small cell lung cancer with activated PI3K pathway

• IRAS ID

  74556

• Sponsor organisation

  Novartis Pharmaceuticals UK Ltd

• Eudract number

  2010-024011-14

• ISRCTN Number

  N/A

• Research summary

  This is a clinical research study sponsored by the pharmaceutical company named Novartis. The goal of this study is to find out if BKM120, a new investigational drug has any effect in patients with non-small cell lung cancer with an activated PI3K pathway.BKM120 belongs to a group of medicines called (phosphatidylinositol 3??-kinase) PI3K inhibitors. It blocks the activity of the PI3K protein which belongs to the PI3K pathway in tumour cells. This pathway is well known to be involved in tumour cell multiplication and survival. Many cancers, such as non-small cell lung cancer, are known to have an activated PI3K pathway. It is thought that BKM120 may stop tumour growth or possibly shrink it. Every patient in stage 1 of this study will receive BKM120. In stage 2 of the study, they will receive either BKM120 or docetaxel or pemetrexed. If the patient is enrolled in stage 2, it will be the study doctor??s decision to choose between docetaxel or pemetrexed. Both docetaxel and pemetrexed are standard treatments for treating this type of cancer. About 180 patients will join this study at approximately 90 centres worldwide. Patients will be asked to come to the hospital clinic approximately every 10 days until the time of disease progression. Some visits may take a few hours.As of 20 August 2010, 78 subjects have been treated with BKM120, either as single-treatment or in combination with another anti-cancer drug. Because this is an investigational compound, the safety and efficacy profile of BKM120 has not yet been established. Access to this investigational compound is available only through carefully controlled and monitored clinical trials. Because of uncertainty of clinical trials, there is no guarantee that BKM120 will ever be commercially available anywhere in the world.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  11/LO/0419

• Date of REC Opinion

  22 Jun 2011

• REC opinion

  Further Information Favourable Opinion