BSMO Sponsored trials

Precision medicine seeks to identify the best treat¬ment for each individual based on the pa¬tient’s unique characteristics. This approach could allow doctors and researchers to predict more accurately which treatment and prevention strategies for a particular disease will work in which groups of people. This new paradigm needs significant changes in clinical trial conduct: a small number of patients that meet very specific protocol requirements.
Precision Belgium (The Belgian Molecular Profiling Program of Metastatic Cancer for Clinical Decision and Treatment Assignment) is a BSMO initiative that aims at expanding genotype-based targeted cancer treatments beyond the strict registered disease associated contexts. This program comprises two initiatives:
PRECISION 1 aims to a) establish an inter-platform cooperation enabling NGS sequencing and some clinical data sharing; b) examine the feasibility and efficiency of using information coming out of this effort to direct patients to existing genotype-based clinical trials.
PRECISION 2 will organize exploratory phase 2 studies in genotypes not covered by available validated treatments or ongoing genotype-based clinical trials. The establishment of a national strategy of systematic genomic characterization of patients with metastatic cancer could foster the implementation of novel genotype driven trials and make the Belgian centers more attractive for such new development trials with new targeted drugs or other genotype-driven treatments by having a pool of patients that have been genotyped. Importantly, for the patients this creates an opportunity to benefit more easily from inclusion in trials with new potentially high impact drugs.

PRECISION 2 clinical trials opened so far:
1. An explorative phase II, open label study of afatinib in advanced cancer carrying an EGFR, a HER2 or a HER3 mutation followed by the addition of paclitaxel to afatinib at disease progression (more information: http://www.cancertrials.be/find-clinical-trials/?id=258)