A phase Ib/II study of BKM 120 in patients with relapsed breast cancer

• Research type

  Research Study

• Full title

  A phase Ib/II open label multicentre study evaluating the safety and efficacy of BKM120 in combination with traztuzumab in patients with relapsing HER2 overexpressing breast cancer who have previously failed traztuzumab.

• IRAS ID

  50060

• Contact name

  Stephen Chan

• Sponsor organisation

  Novartis Pharmaceuticals UK Ltd

• Eudract number

  2009-015417-46

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The purpose of this trial is to assess the safety and efficacy of BKM120 in combination with trestuzumab in patients with HER2 overexprissing metastatic breast cancer that has prograssed on trestuzumab.The Phase Ib part of the study will serve to define the maximum tolerated dose (MTD) of the combination treatment. The final recommended dose for Phase II of BKM120 in combination with trestuzumab will be based on the MTD and an overall assessment of available safety information including tolerability data from subsequent cycles (beyond Cycle 1), taking into account also pharmacokinetic and pharmacodynamic data. The purpose of Phase II is to evaluate activity at the recommended Ph II dose which could be the MTD or a dose lower via measures of efficacy in two disease subtypes defined by the PIK3CA mutational status (PIK3CA wild type (Arm A) and mutated (Arm B).

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  10/H0405/96

• Date of REC Opinion

  17 Jan 2011

• REC opinion

  Further Information Favourable Opinion