Diapositive 1

SAFIR01: Screening Approach For Individualized Regimen
UNICANCER (former French Federation of Cancer Centers)
Background:
SAFIR01 trial: logistics
Need for enrichement of phase I/II trials in patients
with molecular alterations in order to early detect
Responders
= need for molecular screening
Investi
gation
center
Patient inclusion
DNA extraction
Hybridization
Hot spot mutations
Genomic unit
Curie
(Affy 6.0)
Genomic unit
Gustave
Roussy
(Agilent 4*44)
Genomic unit
Lyon
(Affy 6.0)
Genomic unit
Marseille
Agilent
Previous studies have suggested that molecular
Screening testing a few targets are not feasible
There is therefore a need to propose a molecular
Screening with high throughput approaches in
Patients who do not present a PD at the time of
analyses
TRIAL DESIGN
Molecular screening:
Which candidate target ?
Phase I / II trials
Target identification
Quantification genetic instability
Biopsy of metastatic sites
Frozen sample
CGH/hot spot mutations
(PIK3CA/AKT)
PS=0-1, eligible for phase I
SD / PR under treatment
n=400
SAFIR01 trial:
Illustration of a CGH array report
Multiple site biopsies (ongoing amendment)
Trial C
Devlopment of phase II on the « rare » diseases
detected during the program = SAFIR02
Trial D
Trial E
Trial F
Trials
X,Y…
Perspectives
Next generation sequencing (Q2 2012)
Funding: French NCI
Primary endpoint:
% of patients included
in phase I/II trial
according to the profile
Amendment to
Limit inclusions
to 1st and 2nd line
(not enough slots
for phase I/II)
Monthly tumor board
Trial B
Target
identification
Monthly
Accrual
rate
Bioinformatics
Trial A
SAFIR 01
(UNICANCER)
Accrual Rate
Therapy
Randomized trial comparing high throughput
approaches to standard of care