OncologyClinicalTrials.pdf

7/22/2019 OncologyClinicalTrials.pdf

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Wod ca cca a xp nw Zaad

Early PhaseOncologyClinical Trials


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Aucklands medical oncology service

Our catchment is the northern region o New Zealand (Auckland and

Northland) whose population is 1.6 M, and we provide comprehensive

treatment services seeing all types o cancer patients. We are

the largest oncology service in Australasia with eighteen medical

oncologists organised across tumour streams. Most standard

approved therapies are unded/available, including rituzumab,

imatinib, trastuzumab, erlotinib, sunitinib.

Aucklands Medical Oncology Service is aligned with corresponding

haematology, paediatric, radiation and surgical oncology services

organised within a Cancer Health Services Group.

Clinical Trial Regulatory Approval

in New Zealand Obtainedprospectivelyforlegalexemptionfromrequirementfor

regulatory marketing approval

ApprovalgivenbytheMinisterofHealthviathedrugregulatory

agency (MedSae) that acts on advice and recommendations o the

Standing Committee o Therapeutic Trials (SCOTT) or GTAC

SCOTTreviewcarriedoutby3ormoreclinicianswithrelevant

clinicalresearchexpertise

NZrequirementsfollowthoseofFDA,EMEAandTGA

Processcompletewithin14to18daysaftertheMOHhavefeeand

documentation

Carriedoutseparatelybutinparalleltoethicalapproval

Ethical review in New Zealand

Nationalcentralisedethicalreviewprocess

Oneapplicationonlyformulticentretrials

Ethicscommitteereview

Committees meet every 2 weeks

Applications close two weeks prior to meeting

Notication obtained within 1-2 weeks o meeting

Applicantsattendmeetingandareabletoaddressquestionsand

concerns directly

Outstanding issues usually resolved by Chair sign-of

Ethicalratherthanscienticreview(SCOTT)

ParallelreviewofculturalissuesbyMaoriResearchReview

Committee

What you need to know.

Associate Professor Mark McKeage

Mark McKeage is an Associate Professor in

Clinical Pharmacology at The University of

Auckland and a Consultant Medical Oncologist at

Auckland City Hospital.

Prior to establishing his career in academic medical oncology, Mark

acquiredqualificationsinclinicalmedicine(MBChB,Otago),medical

oncology(FRACP)andpostgraduateresearch(MMedSc,Auckland;PhD,

London),andgainedrelevantexperienceabroadintheUnitedKingdom

and Australia.

He has published over 75 journal articles, supervised over 20 graduate

students and received numerous research grants, awards and

prestigious appointments relating to his work on novel anticancerdrugs. He has successully guided the development o several

novel anticancer drugs through their early-phase clinical trials onto

late-phase clinical development, including satraplatin (JM216) and

vadimezan(ASA404,DMXAA).

Mark is dedicated to reducing mortality and morbidity rom cancer

through patient care, education and research that transorms scientiic

discoveries into clinical interventions.

Oncology clinicaltrial experts

Resources for oncology phase I

trials in Auckland

Groupofprincipalinvestigatorsandsupportstaexperienced

in the broad range o oncology phase I and II trials

Largereferral-baseofpatientswithsolidandhaematological

malignancies (ca 3000/annum)

Accesstoimaging(CT,MRI,CT-PET)

Clinicaltrialspharmacyon-site

Prospectivebiomarkeranalysis

Managementofthecontracting,budgetingand

nancial processes


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.Professor Peter Browett

Peter Browett is a Consultant Haematologist

at Auckland City Hospital, and Professorof Pathology and Head of the Department

of Molecular Medicine and Pathology,

University of Auckland.

Proessor Browett is a graduate o the University o Otago School

ofMedicineandhasworkedattheRoyalFreeHospitalSchool

ofMedicineasaresearchfellowintheAcademicDepartmentof

Haematology.PeterisaFellowoftheRoyalAustralasianCollegeof

PhysiciansandtheRoyalCollegeofPathologistsofAustralasia,

and is currently Vice-President o the Haematology Society o

Australia and New Zealand (HSANZ).

His clinical interests include the management o patients with

haematological malignancies, including blood cell and bone marrow

transplantation. In the laboratory, he has an interest in cell marker

and molecular studies in the diagnosis and monitoring o patients

with leukaemias, lymphomas and inherited blood disorders.

Professor Michael Findlay

Michael Findlay works as Consultant Medical

Oncolgist at Auckland City Hospital.He is also the Director of Cancer Trials

New Zealand and Professor of Oncology

at The University of Auckland

MichaelFindlaycompletedhisundergraduatestudiesattheUniversity

ofOtago.HewasawardedhisFellowshipoftheRoyalAustralasian

College o Physicians in 1990 ater training in Wellington and Sydney.

Hispost-Fellowshipresearchinthetreatmentofgastro-intestinal

cancersattheRoyalMarsdenHospitalinLondonresultedinthe

awardingofthedegreeofDoctorofMedicinein1995.

Ater appointments at Sydney Cancer Centre and Wellington Cancer

Centre between 1994 and 2002, he was appointed as the oundation

ProfessorinOncologyattheUniversityofAuckland.Duringhis

appointment he established Cancer Trials New Zealand, a clinical trials

coordinating centre engaged in the design and conduct o clinical and

translational trials in a wide range o cancer types trials that are

considered to be o particular signiicance to New Zealanders.

Other current activities related to cancer and cancer research include:

board director and deputy-chairman o the Australasian Gastro-

IntestinalTrialsGroupanditsScientificAdvisoryCommittee;member

oftheGenesisOncologyTrustScientificEvaluationCommittee;board

memberoftheAucklandDivisionoftheNewZealandCancerSociety;

andmemberoftheNationalEthicsAdvisoryCommittee.

Professor Peter C. Fong

Peter C. Fong is a Medical Oncologist at

Auckland City Hospital, Auckland, New Zealand

since 2008. He is also an Honorary Clinical Senior

Lecturer with the Auckland University Faculty of

Health and Medical Sciences.

PetersinterestsareinDrugDevelopment,Genitourinaryand

Gynaecological cancers especially castrate resistant prostate cancer

and ovarian cancer trials and research. He graduated with irst class

honours rom Queensland University, Australia beore working in

Australia and New Zealand. Peter completed his medical oncology

training at Auckland including a 6 month elective in the Bone Marrow

Transplant unit beore taking up a locum consultant post at Auckland

Hospital in 2003.

From2004to2008,heundertookaclinicalandlaboratoryfellowship

attheRoyalMarsdenHospitalandtheInstituteofCancerResearch

inLondon,UK.Duringthistime,heworkedattheDrugDevelopment

Unit(withStanKayeandJohanndeBono)engagedinrunningover20

phaseItrialsconcurrently.ExamplesoftheseincludethePARPinhibitor,

olaparib,variousHDACinhibitorsandtheIGF1-Rinhibitor,figitumumab.

Peterspent2yearsinpostgraduatesstudiesintheCancerResearch

UKsectionofCancerTherapeuticsLaboratoryintranslationalresearch

o novel biomarkers o histone deacetylase inhibitors including high

throughputELISAvalidationandcirculatingtumourcells.Subsequently

heworkedintheProstateDrugDevelopmentUnitrunningPhaseItoIII

trials, including abiraterone. He has authorednumerous abstracts and

has published in various peer-reviewed journals.

Professor Reuben BroomReuben Broom is a Medical Oncologist at

Auckland City Hospital and an honorary

clinical lecturer in oncology at the

University of Auckland.

He graduated rom medical school, University o Auckland in 1999

andbecameaFellowoftheRoyalAustralasianCollegeofPhysicians

in 2006. Between 2006 2008 he completed a clinical research

ellowship at Princess Margaret Hospital, Toronto, Canada, ocusing

on renal and breast malignancies beore returning to New Zealand.

Reubenisanactiveresearcherinbothbreastandrenalcancers.

He is an investigator on multiple phase II and III clinical trials,

including leading investigator initiated trials. He is also conducting

translational research in these malignancies in collaboration with

several Auckland based laboratories.

The main ocus o his renal cancer research is the issue o bone

metastases a common site o spread in this disease associated with

signiicant morbidity. He is currently running a phase II trial in this

speciic population which includes bone-speciic end-points.


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Auckland UniServices Ltd

Auckland UniServices Limited is the largest research and

development company o its kind in the Southern Hemisphere and a

wholly owned company o The University o Auckland.

By connecting its clients with The Universitys brightest academic

minds, UniServices provides commercial organisations the

innovative technologies they seek, and governments the national

programmes they need. The results can mean huge strides in a

companys international competitive edge, or in a countrys health,

education and welare capability.

UniServices manages all o The Universitys intellectual property

and is responsible or all research-based consultancy partnerships

and commercialisation.

UniServices open innovation and world-class thinking can change

the world.

Contacts

Ca C

Business Manager - Medicine & Health

+64 9 923 2585 or 021 859 188

[email protected]

Adw PaaBusiness Manager - Biomedical Sciences

+64 9 923 8245

[email protected]

Auckland UniServices Limited

Level 10, UniServices House

70 Symonds Street, Auckland

Private Bag 92019 AMC

Auckland 1142, New Zealand

www.uniservices.co.nz

Experts SpecialitiesOverArChing sPeCiAlity(s) sub-sPeCiAlity(s) tyPe (PhAse) Of triAls

Mak McKa Oncology - translational Head and neck cancer, clinical pharmacology and Phase I, II & IIIand clinical research development of anticancer drugs, drug transport,

platinum drugs, chemotherapy neurotoxicity,

tumour vascular disruption, lung cancer

P bow Haematology research Malignant haematology, bone marrow Phase IItransplantation, laboratory diagnosis of

haematological disorders

Mk fda Oncology clinical research Gastrointestinal cancers, clinical trials, Phase II, III & IVexpertise across most types of cancers

through national collaborators

P fo Oncology - translational and Prostate, bladder, testicular, ovarian, endometrial Phase I, II & IIIclinical research

r boom Oncology - translational and Renal and breast cancers, bone metastases Phase II & IIIclinical research

Documents

OncologyClinicalTrials.pdf