ComPAKT - fastest set-up to date

ComPAKT (Combination Alliance study in partnership with AstraZeneca) is a good example of how the ECMC Network and Industry have combined their resources and expertise to address solid tumours.  In fact this study set up has been the fastest to date within the ECMC Combinations Alliance, with the first patient’s first treatment achieved less than 6 months after CR-UK’s New Agents Committee met to approve the trial.

The ComPAKT study is a Phase I trial of the novel combination of the PARP inhibitor Olaparib and the AKT inhibitor AZD5363 in patients with advanced solid tumours. This study is lead by Dr Timothy Yap from the Institute of Cancer Research/ Royal Marsden Hospital ECMC as part of the ECMC Combinations Alliance with AstraZeneca. The study will assess the safety and tolerability of this combination to establish a safe dose of each component drug for use in phase II combination studies. Exploratory translational studies will be undertake whole exome and targeted sequencing on both tumour and sequential plasma specimens from patients.

The Drug Development Unit and investigators in the ICR/ RMH ECMC have extensive experience with investigator-sponsored early phase studies including combinations. Having template agreements in place, teamwork, good a priori planning and being able to share experiences with other ECMCs involved in CA trials has been key to overcoming any unexpected obstacles along the way.