IceCAP-A Phase I trial of ipatasertib in combination with atezolizumab
Research type
Research Study
Full title
Ice-CAP: A Phase I trial of ipatasertib in Combination with atezolizumab in patients with advanced solid tumours with PI3K pathway hyperactivation
IRAS ID
233461
Contact name
Juanita Lopez
Contact email
Sponsor organisation
The Institute of Cancer Research
Eudract number
2017-003005-18
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This is a single centre, proof-of-concept phase I trial. The purpose of this study is to find out the side effects and safety of ipatasertib in combination with atezolizumab in patients with advanced solid tumours with PI3K pathway hyperactivation and to determine the most appropriate dose of this combination. In Part A of this study up to 12 patients with advanced solid tumours (Cohort A1)and 3 patients with resectable glioblastoma multiforme (GBM)(Cohort A2) will be treated with increasing doses of ipatasertib in combination with a fixed dose of enzalutamide(1200mg once daily). Once Part A has been completed the combination with the optimum safety and pharmacokinetic/pharmacodynamic profile will be taken forward to Part B of the study. Part B of the study will evaluate the optimized dose/schedule identified in Part A of the study in in specific subgroups of patients. The specific cohorts are as follows; Cohort B1-patients with solid tumours with hyperactivation of PI3K pathway(n=12), Cohort B2-patients with castrate-resistant prostate cancer with PTEN loss(n=12), Cohort B3-patients with glioblastoma (n=12) of which at least three (n=3) patients will have potentially resectable recurrent glioblastomas.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
18/LO/0059
Date of REC Opinion
7 Feb 2018
REC opinion
Further Information Favourable Opinion