Phase I experience Matteo Carlino Crown Princess Mary Cancer Centre Westmead and Blacktown Hospitals Melanoma Institute Australia The University of Sydney The Westmead and MIA Phase I experience ID: 589708
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The Westmead and MIAPhase I experience
Matteo CarlinoCrown Princess Mary Cancer Centre Westmead and Blacktown HospitalsMelanoma Institute AustraliaThe University of Sydney
.Slide2
The Westmead and MIAPhase I experience
Matteo CarlinoCrown Princess Mary Cancer Centre Westmead and Blacktown HospitalsMelanoma Institute AustraliaThe University of Sydney
.
Howard Gurney
Rick Kefford
Georgina LongSlide3Slide4
Westmead milestones1978-Hospital opens1986- Medical Oncology begins1987 – First trials
Small cell lung cancer (Cyclo and etoposide)Pamidronate in hypercalcaemia (Lancet pubs)1988 – First Pharma studiesRoferon A + DTIC in melanoma1999 – First vaccine trialCancer Vax melanoma2009 – First phase 1DabrafenibSlide5
Dabrafenib-SuccessSlide6
Challenges Rapid increase in work loadDifficulties expanding/training staff within University employment‘non-coordinator’ staff brought into support2 clinical fellows employedMedical students (processing of bloods)
Engagement of the hospital ethics committeeGeorginaFellowship funded academicImpact on support servicesCNCsPall CareSlide7
OpportunitiesSlide8
Impact beyond recruitment Slide9
IO experience History of IO melanoma trialsIFNTremelimumab Slide10
KeyNote-0011st IO Phase I70+ ptsInitially melanoma, subsequently NSCLCFollowed by multiple single agent and combination Ph1 studiesSlide11
Westmead StructurePh1 embedded within trials unitNo dedicated Ph1 coordinatorsNo Ph1 clinicAllows workload to be spreadPts usually managed under the supervision of their own OncologistFellows support clinics with substantial trials
pt loadAdvanced trainees exposed to Ph1 studies3 major teaching hospitals one networkLarge Patient catchmentWeekly meetings to review pts and workloadSeparate start-up and financial specialists Slide12
ChallengesImpact on Cancer servicesPharmacyTrials unit funded pharmacy staff during rapid recruitmentDay WardSatellite day wards used to treat non-trials pt
Study prioritisation for resources. Growth to 22 staff within trials unit2 further trials units set upCollaborative trials unitBlacktownSlide13
Toxicity ManagementInfrastructure of a tertiary hospitalEngaged subspecialty support GastroenterologyAccess to endoscopy at short noticeHepatologistDermatologySlide14
Subspecialty toxicity support
Chmiel K et al J Clin Oncol 29 237 2011.Slide15
Support Slide16
Factors contributing to successPatientsInvestigatorsCollaborationTranslational ScienceSlide17
MIAThanks to Maria GonzalezLarge rapidly expanding trials unit with a strong History of surgical, radiation oncology and cooperative group trialsLast 3-5 years expansion into Ph1 studies, led by Georgina LongSlide18
MIA-Active TrialsSlide19
MIA-ChallengesSetting up a network of providersOften in the pvt systemCostsPublic pts in a pvt chemo unit
Chair costs built into the budgetBudget for O/N admission in the event of an infusion reactionIncreasing number of Basket studiesHistorical melanoma studies on a BRAFi backbone so dominated by melanomaStudies now multitumourSlide20
Challenges in the current eraWhat is the aim of a Phase I study?Pt/referrer expectationsDLT windows, risk of unexpected toxicitiesLack of MTD for many compoundsStudy size and resource allocation We now have ‘Phase I’ studies with 1000s of pts
With an ever expanding pipeline others don’t get off the groundStudies can close earlyLeads to difficulties triaging studiesSlide21
Challenges in the current eraCombinations on a PD1 backbone‘Access program’ vs Phase I studyNo longer limited to pts who have exhausted all treatment options1st line ‘phase I’ studiesSlide22
Thankyou ?Questions?