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SUMMARY:Target-Based Approach in Early-Phase Clinical Trials in Cancer - F
 ilip Janku\, Investigational Cancer Therapeutics\, (Phase I Clinical Trial
 s Program)\, The University of Texas MD Anderson Cancer Center\, Houston
DTSTART:20131001T110000Z
DTEND:20131001T120000Z
UID:TALK45992@talks.cam.ac.uk
CONTACT:Mala Jayasundera
DESCRIPTION:*ABSTRACT:* \n\nPhase I clinical trials in unselected patient 
 populations have typically produced low response rates of 4% to11%. Theref
 ore\, for many decades\, phase I clinical trials have been viewed as merel
 y dose-finding studies with\, at best\, a modest impact on patient outcome
 . It has become clear that the traditionally low response rate historicall
 y seen in early-phase trials can be increased substantially if patient sel
 ection has been driven by molecular matching. Several recent early-phase c
 linical trials using targeted therapies based upon molecular matching demo
 nstrated response rates of 39% to 81% (Table). Novel technologies\, includ
 ing next-generation sequencing\, can yield further insight into the underl
 ying molecular pathology of cancers and concordant sensitivity/resistance 
 mechanisms in response to targeted therapies. It is plausible that druggab
 le molecular abnormalities occur in small subset of patients across differ
 ent histologic types.  Therefore\, testing one molecular abnormality at a 
 time is neither practical nor sustainable. Novel technologies such as next
 -generation sequencing are capable of testing myriad of molecular abnormal
 ities in the whole cancer genome. This provides an unparalleled opportunit
 y to create umbrella protocols to match these molecular abnormalities with
  appropriately selected targeted therapies. Moving from dose-finding studi
 es to better designed clinical trials based on molecular technologies prov
 ides a greater chance of therapeutic benefit and may significantly shorten
  the drug development timeline.\n
LOCATION:CRI Lecture Theatre\, Cambridge Research Institute
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