A phase 1A dose escalation study of BYL719 in advanced solid tumours

• Research type

  Research Study

• Full title

  A phase 1A multicentre open label dose escalation study of oral BYL719 in adult poatients with advanced solid malignancies whose tumours have a mutation of the PIK3CA gene

• IRAS ID

  57671

• Contact name

  Mark Middleton

• Sponsor organisation

  Novartis Pharma Services

• Eudract number

  2010-018782-32

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a first-in-man study, in which BYL719 will be administered to adult patients with advanced solid tumours, whose tumours have a mutation of the PIK3CA gene and whose disease has progressed despite standard therapy or no standard therapy exists. The trial has been designed as a Phase I A dose-escalation trial with a dose expansion arm which will enrol once the maximum tolerated dose has been determined. Both the dose escalation as well as the dose expansion arm will only enroll patients whose tumours have a mutation of the PIK3CA gene. The purpose of the trial is: (i) To determine the maximum tolerated dose (MTD) or recommended Phase II dose of BYL719(ii) To assess the safety and tolerability of this dosage; (iii) To assess preliminary anti-tumour activity; (iv) To assess the pharmacokinetic profile of BYL719; (v) To assess the pharmacodynamic effect, measured by the impact of the drug on various biomarkers. Once MTD has been defined, an expansion arm will open at the MTD level to further characterize the safety, Pharmacokinetic and Pharmacodynamic profile of BYL719 at this dose.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  10/H0606/39

• Date of REC Opinion

  13 Sep 2010

• REC opinion

  Further Information Favourable Opinion