A Study of BYL719 in patients with pNETs, RCC and breast cancer.
Research type
Research Study
Full title
A phase Ib dose-finding study of BYL719 plus everolimus and BYL719 plus everolimus plus exemestane in patients with advanced solid tumors, with dose-expansion cohorts in renal cell cancer (RCC), pancreatic neuroendocrine tumors (pNETs), and advanced breast cancer (BC) patients.
IRAS ID
152947
Contact name
Richard Hubner
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2013-004829-86
Duration of Study in the UK
1 years, 11 months, 29 days
Research summary
This is a multi-center, open-label, dose escalation phase Ib study combining BYL719 and everolimus and BYL719, everolimus and exemestane in patients with advanced solid tumors followed by dose-expansion cohorts in renal cell cancer, pancreatic neuroendocrine tumors, and advanced breast cancer patients.
The purpose of the dose-escalation part is to determine the Maximum Tolerated Dose (MTD) and/or Recomended Dose for Expansion of BYL719 when given in combination with everolimus and BYL719 when given in combination with everolimus and exemestane to patients with advanced solid tumours. Once the the MTD and/or RDE of BYL719 and Everolimus is established in the dose-escalation part of the study, the combination of BYL719 and everolimus will be explored in two separate expansion cohorts in patients with advanced Renal Cell Carcinoma (RCC) (n=20) and patients with pancreatic neuro endocrine tumours (pNETs) (n=20) patients.
In addition, another dose-expansion cohort including advanced solid tumour patients
(n=10, all histologies) who had previously received and progressed to an mTOR inhibitor will be explored in order to help determine the role of PI3K inhibition in patients previously exposed to mTOR treatment.
Once the the MTD and/or RDE of BYL719 + Everolimus is established in the dose-escalation part of the study, the MTD and/or the RDE of BYL719 and everolimus and
exemestane (triplet combination) will be assessed in hormone receptor (HR)-positive HER2-negative advanced breast cancer patients. Once the MTD and/or the RDE of the triplet is determined, two expansion cohorts will be analyzed: HR-positive HER2-negative advanced breast cancer patients who have not received prior mTOR treatment (n=40) and mTOR inhibitor-pretreated advanced HR-positive HER2-negative breast cancer patients (n=10).The UK will only participate in the dose expansion phase of the study.
REC name
London - Central Research Ethics Committee
REC reference
14/LO/1868
Date of REC Opinion
9 Feb 2015
REC opinion
Further Information Favourable Opinion